Hiroshi KatayamapersName, Yukinori KurokawapersName, Kenichi NakamurapersName, Hiroyuki ItopersName, Yukihide KanemitsupersName, Norikazu MasudapersName, Yasuhiro TsubosapersName, Toyomi SatohpersName, Akira YokomizopersName, Haruhiko FukudapersName, Mitsuru SasakopersName (2016date). “Extended Clavien-Dindo classification of surgical complications: Japan Clinical Oncology Group postoperative complications criteria.” Surgery Todaytitle·venue.
Object of study — A SEVERITYterm CLASSIFICATION BEING EXTENDED BY A SECOND COMMITTEE - 72 named surgical adverse eventsterm given per-event grading criteria under somebody else's five-grade scheme, across nine surgical specialities
Research question — why the Clavien-Dindo classificationterm·mth is hard to apply consistently in surgical trials, and what supplementary criteria would make the counts comparable between trials
Contribution — the JCOG postoperative complications criteria: 72 AE terms with detailed per-term grading, published as a supplement to the Clavien-Dindo classificationterm·mth rather than as a replacement
phenomenon · claim-type · cross-domain-transfer · mechanism · claim-relation · replication-status · limitation — grounded in the full text| phenomenon | an adverse event whose incidence cannot be counted because the same event is reported under three different names — “One controversial issue is that AE terms are not well defined and different AE terms designate the same AEs in different clinical trials. For example, when intestinal obstruction occurs, some investigators could report this AE as “ileus”, but others refer to it as “small bowel obstruction” or “colon obstruction”. Under such circumstances, the incidence of this AE cannot be counted accurately.” | |
| claim-type | method — “The JCOG PC criteria included 72 surgical AEs experienced commonly in surgical trials, including 17 gastroenterological complications, 13 infectious complications, six thoracic complications, and several other complications” | |
| method — evidence | — “The JCOG PC criteria have some limitations. First, these AE terms were chosen somewhat arbitrarily, but by experienced surgeons, and specific grading was decided based on the opinions and experience of our committee members.” | |
| object of study — evidence | — “The JCOG PC criteria included 72 surgical AEs experienced commonly in surgical trials, including 17 gastroenterological complications, 13 infectious complications, six thoracic complications, and several other complications” | |
| research question — evidence | — “One controversial issue is that AE terms are not well defined and different AE terms designate the same AEs in different clinical trials. For example, when intestinal obstruction occurs, some investigators could report this AE as “ileus”, but others refer to it as “small bowel obstruction” or “colon obstruction”. Under such circumstances, the incidence of this AE cannot be counted accurately.” | |
| contribution — evidence | — “The JCOG PC criteria included 72 surgical AEs experienced commonly in surgical trials, including 17 gastroenterological complications, 13 infectious complications, six thoracic complications, and several other complications” | |
| mechanism | THREE NAMES, ONE EVENT, AND THE COUNT BREAKS: `different AE terms designate the same AEs in different clinical trials ... some investigators could report this AE as `ILEUS`, but others refer to it as `SMALL BOWEL OBSTRUCTION` or `COLON OBSTRUCTION`. Under such circumstances, the incidence of this AE cannot be counted accurately.` Synonymy stated as a measurement failure, with the mechanism named — “One controversial issue is that AE terms are not well defined and different AE terms designate the same AEs in different clinical trials. For example, when intestinal obstruction occurs, some investigators could report this AE as “ileus”, but others refer to it as “small bowel obstruction” or “colon obstruction”. Under such circumstances, the incidence of this AE cannot be counted accurately.” | mechanisms[0] |
| mechanism | AND BEFORE THE CLASSIFICATION THERE WAS NOTHING: `Prior to publication of the Clavien-Dindo classification in 2004, there were no grading definitions for surgical complications in either clinical practice or surgical trials` - and what filled the gap was personal: `individual parochial definitions of surgical complications being used in most surgical RCTs` — “Prior to publication of the Clavien-Dindo classification in 2004, there were no grading definitions for surgical complications in either clinical practice or surgical trials.” | mechanisms[1] |
| mechanism | and the disagreement is shown rather than asserted: `some surgeons INCLUDED A body temperature greater than 38 C on two consecutive days as being `high`, whereas others included intraoperative complications, postoperative complications (within 30 days), and late events such as dumping syndrome`. One word, two populations of events — “For instance, some surgeons included a body temperature greater than 38 °C on two consecutive days as being “high”, whereas others included intraoperative complications, postoperative complications (within 30 days), and late events such as dumping syndrome.” | mechanisms[2] |
| mechanism | A DEFINITION BORROWED FROM THE WRONG OBJECT: `the grading definition of pancreatic fistula in this version of the CTCAE is suitable for pancreatitis, but not for pancreatic fistula after pancreatectomy. Such inappropriate definitions have made surgeons reluctant to use the CTCAE version 4.0 in surgical trials`. The criterion fits the neighbouring condition, and the vocabulary loses its users over it — “Moreover, grading definitions were not clinically optimized for some surgical AEs. For example, the grading definition of pancreatic fistula in this version of the CTCAE is suitable for pancreatitis, but not for pancreatic fistula after pancreatectomy. Such inappropriate definitions have made surgeons reluctant to use the CTCAE version 4.0 in surgical trials.” | mechanisms[3] |
| mechanism | AND A REAL CASE THE CLASSIFICATION SIMPLY DOES NOT GRADE: `primary non-operative treatment for intestinal obstruction is gastroenteric tube decompression ... but the original Clavien-Dindo classification does not define what grading should be applied for any type of gastroenteric tube placement for decompression`. A gap located by trying to use the thing — “A second issue is that only general grading criteria are defined and therefore, grading can be difficult in some cases and subject to bias by the grader. For example, primary non-operative treatment for intestinal obstruction is gastroenteric tube decompression. Nasogastric tube or nasoenteric tube is utilized depending on the severity, but the original Clavien-Dindo classification does not define what grading should be applied for any type of gastroenteric tube placement for decompression.” | mechanisms[4] |
| mechanism | and the general/specific trade-off is stated outright: `Rather than providing specific grading criteria for each AE, the Clavien-Dindo classification provides broad-based but general criteria that can be used uniformly for all kinds of surgical AEs`. Generality is what makes it adoptable and what makes it ungradeable in the hard cases — “Rather than providing specific grading criteria for each AE, the Clavien-Dindo classification provides broad-based but general criteria that can be used uniformly for all kinds of surgical AEs.” | mechanisms[5] |
| mechanism | THE SCALE IS NAMED FOR ONE THING AND BUILT OUT OF ANOTHER: `five grades of SEVERITY`, and every boundary is an INTERVENTION - `without the need for pharmacological treatment`, then `Requirement for pharmacological treatment`, then a procedure without general anaesthesia, then one under it, then ICU. The instrument measures what the hospital did, and reports it as how bad it was. — “Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, or radiological interventions. Allowed therapeutic regimens include drugs such as antiemetics, antipyretics, analgesics, diuretics, electrolytes, and physiotherapy. This grade also includes wound infections opened at the bedside Requirement for pharmacological treatment with drugs other than those allowed for grade I complications Blood transfusions and total parenteral nutrition are also included Requirement for surgical, endoscopic or radiological intervention not under general anesthesia Requirement for surgical, endoscopic or radiological intervention under general anesthesia” | mechanisms[6] |
| mechanism | AND THE ONE DIMENSION THAT WILL NOT SIT ON THAT LADDER IS BOLTED ON AS A SUFFIX: `the suffix “d” (for “disability”) is added to the respective grade` - persistence at discharge cannot be ranked against treatment intensity, so it is carried beside the grade instead of inside it. — “If the patient suffers from a complication at the time of discharge, the suffix “d” (for “disability”) is added to the respective grade of complication. This label indicates the need for a follow-up to fully evaluate the complication” | mechanisms[7] |
| mechanism | THE FIX FOR GRADER DISAGREEMENT IS ITSELF OPTIONAL: `surgeons can use these original rules to grade AEs, and can also refer to the more detailed definitions in the JCOG PC criteria if necessary`. The paper's stated problem is that graders disagree; its remedy is a supplement they may consult at their discretion, so two graders following this paper correctly can still disagree. — “Because the grading definitions follow the general rules of the Clavien-Dindo classification, surgeons can use these original rules to grade AEs, and can also refer to the more detailed definitions in the JCOG PC criteria if necessary” | mechanisms[8] |
| extends | the Clavien-Dindo classification (Dindo, Demartines and Clavien 2004), whose general grading rules these 72 per-term criteria are written under rather than replacing — “Rather than providing specific grading criteria for each AE, the Clavien-Dindo classification provides broad-based but general criteria that can be used uniformly for all kinds of surgical AEs.” | claim_relations[0] |
| contrasts-with | the CTCAE version 4.0, which the authors say omits common surgical complications and grades others by definitions written for different conditions — “In 2009, the CTCAE version 4.0 [ 11 ] was released, with considerably more surgical AE terms, but several common surgical complications were still not included. For example, intra-abdominal abscess, pyothorax, delayed gastric emptying, and lung torsion were not listed as AE terms.” | claim_relations[1] |
| sense | `ileus` / `small bowel obstruction` / `colon obstruction` - THREE REPORTING NAMES FOR ONE EVENT, and the paper's reason for existing: `Under such circumstances, the incidence of this AE cannot be counted accurately` — “One controversial issue is that AE terms are not well defined and different AE terms designate the same AEs in different clinical trials. For example, when intestinal obstruction occurs, some investigators could report this AE as “ileus”, but others refer to it as “small bowel obstruction” or “colon obstruction”. Under such circumstances, the incidence of this AE cannot be counted accurately.” | senses[0] |
| sense | `high` (of a postoperative temperature) - `some surgeons INCLUDED A body temperature greater than 38 C on two consecutive days as being `high`, whereas others` counted an entirely different set of events. The word survived; the referent did not — “For instance, some surgeons included a body temperature greater than 38 °C on two consecutive days as being “high”, whereas others included intraoperative complications, postoperative complications (within 30 days), and late events such as dumping syndrome.” | senses[1] |
| sense | `pancreatic fistula` (CTCAE 4.0 sense) - graded by a definition that `is suitable for pancreatitis, but not for pancreatic fistula after pancreatectomy`. The term is in the vocabulary and its criteria belong to a different condition — “Moreover, grading definitions were not clinically optimized for some surgical AEs. For example, the grading definition of pancreatic fistula in this version of the CTCAE is suitable for pancreatitis, but not for pancreatic fistula after pancreatectomy. Such inappropriate definitions have made surgeons reluctant to use the CTCAE version 4.0 in surgical trials.” | senses[2] |
| sense | `CTCAE` - the vocabulary that was `NCI-CTC version 2.0` until 2003, when it was `revised and renamed the CTCAE version 3.0`. One instrument, two names, a date — “In 2003, the US National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 2.0 [ 9 ] were revised and renamed the CTCAE version 3.0 [ 10 ]. This system has been used widely to evaluate and define the toxicity of chemotherapy or radiotherapy.” | senses[3] |
| sense | `other (specify)` - THE OPEN SLOT THE CONTROLLED VOCABULARY SHIPS WITH: `If no applicable AE terms are found in the JCOG PC criteria, `other (specify)` should be chosen`, after which the general Clavien-Dindo rules apply — “If no applicable AE terms are found in the JCOG PC criteria, ‘other (specify)’ should be chosen. In such cases, the appropriate AE term should be used, and the overall grading should be performed in accordance with the general rules of the Clavien-Dindo classification.” | senses[4] |
| sense | `severity` IS OPERATIONALISED AS TREATMENT INTENSITY. Grade I is `Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, or radiological interventions` - defined by what is NOT required. A patient who suffers greatly and needs nothing is grade I. — “Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, or radiological interventions. Allowed therapeutic regimens include drugs such as antiemetics, antipyretics, analgesics, diuretics, electrolytes, and physiotherapy. This grade also includes wound infections opened at the bedside” | senses[5] |
| sense | `early postoperative` IS AN ADMINISTRATIVE BOUNDARY, NOT A CLINICAL ONE: `generally indicates the time from surgery to the first hospital discharge` - and the paper adds `but in theory` the classification reaches past it, so the scope moves with discharge policy. — “Here, ‘early postoperative’ generally indicates the time from surgery to the first hospital discharge, but in theory, the Clavien-Dindo classification can be applied broadly to late postoperative complications after hospital discharge” | senses[6] |
| control | writing the new criteria under the existing Clavien-Dindo grading rules rather than as an independent scheme — held — “Rather than providing specific grading criteria for each AE, the Clavien-Dindo classification provides broad-based but general criteria that can be used uniformly for all kinds of surgical AEs.” — rules out a fourth incompatible vocabulary - 'surgeons can use these original rules to grade AEs, and can also refer to the more detailed definitions ... if necessary' — “If no applicable AE terms are found in the JCOG PC criteria, ‘other (specify)’ should be chosen. In such cases, the appropriate AE term should be used, and the overall grading should be performed in accordance with the general rules of the Clavien-Dindo classification.” | controls[0] |
| control | an 'other (specify)' term for events the list does not name — partial — “One controversial issue is that AE terms are not well defined and different AE terms designate the same AEs in different clinical trials. For example, when intestinal obstruction occurs, some investigators could report this AE as “ileus”, but others refer to it as “small bowel obstruction” or “colon obstruction”. Under such circumstances, the incidence of this AE cannot be counted accurately.” — rules out forced mis-classification into the nearest listed term - the failure that creates 'ileus' / 'small bowel obstruction' in the first place — “If no applicable AE terms are found in the JCOG PC criteria, ‘other (specify)’ should be chosen. In such cases, the appropriate AE term should be used, and the overall grading should be performed in accordance with the general rules of the Clavien-Dindo classification.” | controls[1] |
| control | a concordance study between CTCAE grading and JCOG PC grading of the same events — absent-declared-unreported — “In JCOG, some disease-oriented subgroups are conducting clinical trials including surgery and using both the CTCAE and JCOG PC criteria to evaluate postoperative complications. After these trials are completed, we will evaluate the concordance between the grading by the CTCAE and that by the JCOG PC criteria. We also plan to explore the advantages and disadvantages of the JCOG PC criteria.” — rules out nothing yet - it is announced as future work: 'After these trials are completed, we will evaluate the concordance' — “In JCOG, some disease-oriented subgroups are conducting clinical trials including surgery and using both the CTCAE and JCOG PC criteria to evaluate postoperative complications. After these trials are completed, we will evaluate the concordance between the grading by the CTCAE and that by the JCOG PC criteria. We also plan to explore the advantages and disadvantages of the JCOG PC criteria.” | controls[2] |
| control | a systematic or frequency-based procedure for choosing which 72 AE terms to list — failed — “The JCOG PC criteria have some limitations. First, these AE terms were chosen somewhat arbitrarily, but by experienced surgeons, and specific grading was decided based on the opinions and experience of our committee members.” — rules out nothing - the authors state there was none: 'these AE terms were chosen somewhat arbitrarily ... based on the opinions and experience of our committee members' — “The JCOG PC criteria have some limitations. First, these AE terms were chosen somewhat arbitrarily, but by experienced surgeons, and specific grading was decided based on the opinions and experience of our committee members.” | controls[3] |
| weight | the Clavien-Dindo classification (Dindo, Demartines and Clavien 2004), whose general grading rules these 72 per-term criteria are written under rather than replacing — 0.95 — “Rather than providing specific grading criteria for each AE, the Clavien-Dindo classification provides broad-based but general criteria that can be used uniformly for all kinds of surgical AEs.” | claim_relations[0] |
| weight | the CTCAE version 4.0, which the authors say omits common surgical complications and grades others by definitions written for different conditions — 0.85 — “In 2009, the CTCAE version 4.0 [ 11 ] was released, with considerably more surgical AE terms, but several common surgical complications were still not included. For example, intra-abdominal abscess, pyothorax, delayed gastric emptying, and lung torsion were not listed as AE terms.” | claim_relations[1] |
| note | ileus —same-as→ small bowel obstruction — NO CUE ATTESTS THIS EDGE AND THE ONLY CUE IN THE SENTENCE POINTS THE OTHER WAY. The sentence is 'different AE terms designate the same AEs', so DIFFERENTIATION fires on 'different' - which describes the TERMS while the relation between the CONCEPTS is identity. A cue-driven typer writes 'distinct-from' here, the exact opposite of what the paper says, and the paper's whole point is that the confusion destroys the count: 'the incidence of this AE cannot be counted accurately' — “One controversial issue is that AE terms are not well defined and different AE terms designate the same AEs in different clinical trials. For example, when intestinal obstruction occurs, some investigators could report this AE as “ileus”, but others refer to it as “small bowel obstruction” or “colon obstruction”. Under such circumstances, the incidence of this AE cannot be counted accurately.” | concept_edges[0] |
| weight | ileus —same-as→ small bowel obstruction — 0.95 — “One controversial issue is that AE terms are not well defined and different AE terms designate the same AEs in different clinical trials. For example, when intestinal obstruction occurs, some investigators could report this AE as “ileus”, but others refer to it as “small bowel obstruction” or “colon obstruction”. Under such circumstances, the incidence of this AE cannot be counted accurately.” | concept_edges[0] |
| note | pancreatic fistula —distinct-from→ pancreatitis — 'the grading definition of pancreatic fistula in this version of the CTCAE is suitable for pancreatitis, but not for pancreatic fistula after pancreatectomy'. The two are distinct and the published criteria for one were written for the other - which is why 'surgeons were RELUCTANT TO USE the CTCAE version 4.0' — “Moreover, grading definitions were not clinically optimized for some surgical AEs. For example, the grading definition of pancreatic fistula in this version of the CTCAE is suitable for pancreatitis, but not for pancreatic fistula after pancreatectomy. Such inappropriate definitions have made surgeons reluctant to use the CTCAE version 4.0 in surgical trials.” | concept_edges[1] |
| weight | pancreatic fistula —distinct-from→ pancreatitis — 0.95 — “Moreover, grading definitions were not clinically optimized for some surgical AEs. For example, the grading definition of pancreatic fistula in this version of the CTCAE is suitable for pancreatitis, but not for pancreatic fistula after pancreatectomy. Such inappropriate definitions have made surgeons reluctant to use the CTCAE version 4.0 in surgical trials.” | concept_edges[1] |
| audit | NCI-CTC —renamed-across-fields→ CTCAE — Audit 2026-09-28: DOUBTFUL - read against its span and kept, but a criteria set was revised and renamed by one institute; renamed-across-fields overstates. — “In 2003, the US National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 2.0 [ 9 ] were revised and renamed the CTCAE version 3.0 [ 10 ]. This system has been used widely to evaluate and define the toxicity of chemotherapy or radiotherapy.” | concept_edges[2] |
| note | NCI-CTC —renamed-across-fields→ CTCAE — 'In 2003, the US National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 2.0 were revised and renamed the CTCAE version 3.0'. THE AXIS IS VERSION AND DATE, NOT FIELD - the second instance in this session, after liu2020's 'clinical decision support systems' -> 'artificial intelligence'. asks for a 'renamed-over-time' type; until it exists this is the closest available and the note carries the correction — “In 2003, the US National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 2.0 [ 9 ] were revised and renamed the CTCAE version 3.0 [ 10 ]. This system has been used widely to evaluate and define the toxicity of chemotherapy or radiotherapy.” | concept_edges[2] |
| weight | NCI-CTC —renamed-across-fields→ CTCAE — 0.9 — “In 2003, the US National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 2.0 [ 9 ] were revised and renamed the CTCAE version 3.0 [ 10 ]. This system has been used widely to evaluate and define the toxicity of chemotherapy or radiotherapy.” | concept_edges[2] |
| note | gastroenterological complications —part-of→ JCOG PC criteria — 'The JCOG PC criteria included 72 surgical AEs ... including 17 gastroenterological complications, 13 infectious complications, six thoracic complications, and several other complications' — “The JCOG PC criteria included 72 surgical AEs experienced commonly in surgical trials, including 17 gastroenterological complications, 13 infectious complications, six thoracic complications, and several other complications” | concept_edges[3] |
| weight | gastroenterological complications —part-of→ JCOG PC criteria — 0.95 — “The JCOG PC criteria included 72 surgical AEs experienced commonly in surgical trials, including 17 gastroenterological complications, 13 infectious complications, six thoracic complications, and several other complications” | concept_edges[3] |
| outcome | control — held — “If no applicable AE terms are found in the JCOG PC criteria, ‘other (specify)’ should be chosen. In such cases, the appropriate AE term should be used, and the overall grading should be performed in accordance with the general rules of the Clavien-Dindo classification.” — “Rather than providing specific grading criteria for each AE, the Clavien-Dindo classification provides broad-based but general criteria that can be used uniformly for all kinds of surgical AEs.” | controls[0] |
| outcome | control — partial — “If no applicable AE terms are found in the JCOG PC criteria, ‘other (specify)’ should be chosen. In such cases, the appropriate AE term should be used, and the overall grading should be performed in accordance with the general rules of the Clavien-Dindo classification.” — “One controversial issue is that AE terms are not well defined and different AE terms designate the same AEs in different clinical trials. For example, when intestinal obstruction occurs, some investigators could report this AE as “ileus”, but others refer to it as “small bowel obstruction” or “colon obstruction”. Under such circumstances, the incidence of this AE cannot be counted accurately.” | controls[1] |
| outcome | control — absent-declared-unreported — “In JCOG, some disease-oriented subgroups are conducting clinical trials including surgery and using both the CTCAE and JCOG PC criteria to evaluate postoperative complications. After these trials are completed, we will evaluate the concordance between the grading by the CTCAE and that by the JCOG PC criteria. We also plan to explore the advantages and disadvantages of the JCOG PC criteria.” | controls[2] |
| outcome | control — failed — “The JCOG PC criteria have some limitations. First, these AE terms were chosen somewhat arbitrarily, but by experienced surgeons, and specific grading was decided based on the opinions and experience of our committee members.” | controls[3] |
| limitation | THE COMMITTEE DECLARES ITS OWN TERM SELECTION ARBITRARY: `these AE terms were chosen somewhat arbitrarily, but by experienced surgeons, and specific grading was decided based on the opinions and experience of our committee members`. No corpus, no frequency count, no vote threshold - stated plainly as the first limitation — “The JCOG PC criteria have some limitations. First, these AE terms were chosen somewhat arbitrarily, but by experienced surgeons, and specific grading was decided based on the opinions and experience of our committee members.” | limitations[0] |
| limitation | AND THE AGREEMENT STUDY IS FUTURE WORK: `some disease-oriented subgroups are conducting clinical trials ... using both the CTCAE and JCOG PC criteria ... After these trials are completed, we will evaluate the concordance between the grading by the CTCAE and that by the JCOG PC criteria`. The vocabulary is published first and measured later — “In JCOG, some disease-oriented subgroups are conducting clinical trials including surgery and using both the CTCAE and JCOG PC criteria to evaluate postoperative complications. After these trials are completed, we will evaluate the concordance between the grading by the CTCAE and that by the JCOG PC criteria. We also plan to explore the advantages and disadvantages of the JCOG PC criteria.” | limitations[1] |
| limitation | AND THE SCOPE IS CLOSED BY FIAT, WITH THE REASON GIVEN: `they do not include intraoperative complications ... we considered that incorporating intraoperative complications would deviate too much from the original concept. Another common classification may be required to define and grade intraoperative complications`. Fidelity to the parent vocabulary chosen over coverage — “A second limitation of the JCOG PC criteria is that they do not include intraoperative complications. Our intent was to further define and clarify the criteria of the Clavien-Dindo classification and we considered that incorporating intraoperative complications would deviate too much from the original concept. Another common classification may be required to define and grade intraoperative complications.” | limitations[2] |
| limitation | and the temporal boundary is admitted to be conventional rather than principled: `here, EARLY POSTOPERATIVE GENERALLY INDICATES the time from surgery to the first hospital discharge, BUT IN THEORY, the Clavien-Dindo classification can be applied broadly to late postoperative complications after hospital discharge` — “A third limitation is that all descriptions in the Clavien-Dindo classification pertain to early postoperative complications. Here, ‘early postoperative’ generally indicates the time from surgery to the first hospital discharge, but in theory, the Clavien-Dindo classification can be applied broadly to late postoperative complications after hospital discharge.” | limitations[3] |
| limitation | THE SAME CLASSIFICATION IS COUNTED THREE WAYS IN THIS ONE PAPER: `broadly into four major groups` in the introduction, and `five grades of severity (Grade I, II, IIIa, IIIb, IVa, IVb, and V)` in the discussion - a parenthetical that enumerates SEVEN labels for the five it announces. `Grade` and `class` are different units and one word is doing both jobs — “This revised version defines five grades of severity (Grade I, II, IIIa, IIIb, IVa, IVb, and V) and the suffix “d” (for “disability”) is used to denote any postoperative impairment” | limitations[4] |
| limitation | THE THREE VIRTUES ARE CITED, NOT MEASURED: `because it is simple, reproducible, and flexible [ 12 ]`. Reproducibility is the exact property this paper's own examples put in doubt - the same fever graded differently by different surgeons - and it is supported here by a reference rather than by a concordance study, which the paper elsewhere says is still future work. — “This refined Clavien-Dindo classification has been used increasingly in clinical practice and also in clinical trials involving surgical procedures, because it is simple, reproducible, and flexible” | limitations[5] |
| limitation | THE COMPARISON THAT JUSTIFIES THE PAPER IS A THREE-CELL TABLE: `AE terms Specified Not specified Specified` and `Grading definitions Defined for each AE Single common definition for all AEs Defined for each AE`. The new instrument's advantage over CTCAE 4.0 is stated as a shared row value, with no measurement of either. — “Table 2 Characteristics of the three criteria CTCAE ver4.0 Clavien-Dindo classification JCOG PC criteria AE terms Specified Not specified Specified Grading definitions Defined for each AE Single common definition for all AEs Defined for each AE (following the general definition of the Clavien-Dindo classification)” | limitations[6] |
finding · quantity · variable · definition · key-term — grounded in the full text| finding | — “One controversial issue is that AE terms are not well defined and different AE terms designate the same AEs in different clinical trials. For example, when intestinal obstruction occurs, some investigators could report this AE as “ileus”, but others refer to it as “small bowel obstruction” or “colon obstruction”. Under such circumstances, the incidence of this AE cannot be counted accurately.” | content_tags.findings[0] |
| finding | — “Prior to publication of the Clavien-Dindo classification in 2004, there were no grading definitions for surgical complications in either clinical practice or surgical trials.” | content_tags.findings[1] |
| finding | — “For instance, some surgeons included a body temperature greater than 38 °C on two consecutive days as being “high”, whereas others included intraoperative complications, postoperative complications (within 30 days), and late events such as dumping syndrome.” | content_tags.findings[2] |
| finding | — “Moreover, grading definitions were not clinically optimized for some surgical AEs. For example, the grading definition of pancreatic fistula in this version of the CTCAE is suitable for pancreatitis, but not for pancreatic fistula after pancreatectomy. Such inappropriate definitions have made surgeons reluctant to use the CTCAE version 4.0 in surgical trials.” | content_tags.findings[3] |
| finding | — “In 2009, the CTCAE version 4.0 [ 11 ] was released, with considerably more surgical AE terms, but several common surgical complications were still not included. For example, intra-abdominal abscess, pyothorax, delayed gastric emptying, and lung torsion were not listed as AE terms.” | content_tags.findings[4] |
| finding | — “A second issue is that only general grading criteria are defined and therefore, grading can be difficult in some cases and subject to bias by the grader. For example, primary non-operative treatment for intestinal obstruction is gastroenteric tube decompression. Nasogastric tube or nasoenteric tube is utilized depending on the severity, but the original Clavien-Dindo classification does not define what grading should be applied for any type of gastroenteric tube placement for decompression.” | content_tags.findings[5] |
| finding | — “The JCOG PC criteria have some limitations. First, these AE terms were chosen somewhat arbitrarily, but by experienced surgeons, and specific grading was decided based on the opinions and experience of our committee members.” | content_tags.findings[6] |
| finding | — “In JCOG, some disease-oriented subgroups are conducting clinical trials including surgery and using both the CTCAE and JCOG PC criteria to evaluate postoperative complications. After these trials are completed, we will evaluate the concordance between the grading by the CTCAE and that by the JCOG PC criteria. We also plan to explore the advantages and disadvantages of the JCOG PC criteria.” | content_tags.findings[7] |
| finding | — “This revised version defines five grades of severity (Grade I, II, IIIa, IIIb, IVa, IVb, and V) and the suffix “d” (for “disability”) is used to denote any postoperative impairment” | content_tags.findings[8] |
| finding | — “A second limitation of the JCOG PC criteria is that they do not include intraoperative complications. Our intent was to further define and clarify the criteria of the Clavien-Dindo classification and we considered that incorporating intraoperative complications would deviate too much from the original concept. Another common classification may be required to define and grade intraoperative complications.” | content_tags.findings[9] |
| finding | — “If no applicable AE terms are found in the JCOG PC criteria, ‘other (specify)’ should be chosen. In such cases, the appropriate AE term should be used, and the overall grading should be performed in accordance with the general rules of the Clavien-Dindo classification.” | content_tags.findings[10] |
| quantity | 72 AE terms — the size of the JCOG PC criteria list - 17 gastroenterological, 13 infectious, six thoracic and others — “The JCOG PC criteria included 72 surgical AEs experienced commonly in surgical trials, including 17 gastroenterological complications, 13 infectious complications, six thoracic complications, and several other complications” | content_tags.quantities[0] |
| quantity | 38 degrees C — the temperature some surgeons required on two consecutive days before calling a postoperative fever 'high', while others counted entirely different events — “For instance, some surgeons included a body temperature greater than 38 °C on two consecutive days as being “high”, whereas others included intraoperative complications, postoperative complications (within 30 days), and late events such as dumping syndrome.” | content_tags.quantities[1] |
| quantity | 30 days — the postoperative window other surgeons used instead - one of the boundaries that made the same word cover different populations of events — “For instance, some surgeons included a body temperature greater than 38 °C on two consecutive days as being “high”, whereas others included intraoperative complications, postoperative complications (within 30 days), and late events such as dumping syndrome.” | content_tags.quantities[2] |
| quantity | 5 grades — the number of severity grades the discussion announces, in a sentence whose own parenthetical then lists seven labels — “This revised version defines five grades of severity (Grade I, II, IIIa, IIIb, IVa, IVb, and V) and the suffix “d” (for “disability”) is used to denote any postoperative impairment” | content_tags.quantities[3] |
| quantity | 4 major groups — the number the introduction gives for the same classification — “Although this classification categorizes postoperative complications broadly into four major groups, it is often desirable to more clearly define the common AEs to avoid the use of different or less precise terms for the same AEs occurring in different clinical trials.” | content_tags.quantities[4] |
| variable | ileus — “One controversial issue is that AE terms are not well defined and different AE terms designate the same AEs in different clinical trials. For example, when intestinal obstruction occurs, some investigators could report this AE as “ileus”, but others refer to it as “small bowel obstruction” or “colon obstruction”. Under such circumstances, the incidence of this AE cannot be counted accurately.” | content_tags.variables[0] |
| definition | JCOG PC criteria — “The JCOG PC criteria included 72 surgical AEs experienced commonly in surgical trials, including 17 gastroenterological complications, 13 infectious complications, six thoracic complications, and several other complications” | content_tags.definitions[0] |
| definition | other (specify) — “If no applicable AE terms are found in the JCOG PC criteria, ‘other (specify)’ should be chosen. In such cases, the appropriate AE term should be used, and the overall grading should be performed in accordance with the general rules of the Clavien-Dindo classification.” | content_tags.definitions[1] |
| definition | early postoperative — “A third limitation is that all descriptions in the Clavien-Dindo classification pertain to early postoperative complications. Here, ‘early postoperative’ generally indicates the time from surgery to the first hospital discharge, but in theory, the Clavien-Dindo classification can be applied broadly to late postoperative complications after hospital discharge.” | content_tags.definitions[2] |
| concept | ileus — not defined in this paper's own words; one of three names investigators use for the same intestinal obstruction event — “One controversial issue is that AE terms are not well defined and different AE terms designate the same AEs in different clinical trials. For example, when intestinal obstruction occurs, some investigators could report this AE as “ileus”, but others refer to it as “small bowel obstruction” or “colon obstruction”. Under such circumstances, the incidence of this AE cannot be counted accurately.” | concepts[0] |
| concept | small bowel obstruction — not defined in this paper's own words; a second name for the same event, used by other investigators in other trials — “One controversial issue is that AE terms are not well defined and different AE terms designate the same AEs in different clinical trials. For example, when intestinal obstruction occurs, some investigators could report this AE as “ileus”, but others refer to it as “small bowel obstruction” or “colon obstruction”. Under such circumstances, the incidence of this AE cannot be counted accurately.” | concepts[1] |
| concept | pancreatic fistula — not defined in this paper's own words; the complication whose CTCAE 4.0 grading definition was written for a different condition — “Moreover, grading definitions were not clinically optimized for some surgical AEs. For example, the grading definition of pancreatic fistula in this version of the CTCAE is suitable for pancreatitis, but not for pancreatic fistula after pancreatectomy. Such inappropriate definitions have made surgeons reluctant to use the CTCAE version 4.0 in surgical trials.” | concepts[2] |
| concept | pancreatitis — not defined in this paper's own words; the condition the CTCAE grading definition actually fits — “Moreover, grading definitions were not clinically optimized for some surgical AEs. For example, the grading definition of pancreatic fistula in this version of the CTCAE is suitable for pancreatitis, but not for pancreatic fistula after pancreatectomy. Such inappropriate definitions have made surgeons reluctant to use the CTCAE version 4.0 in surgical trials.” | concepts[3] |
| concept | NCI-CTC — not defined in this paper's own words; the US National Cancer Institute Common Toxicity Criteria, version 2.0, before the 2003 rename — “In 2003, the US National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 2.0 [ 9 ] were revised and renamed the CTCAE version 3.0 [ 10 ]. This system has been used widely to evaluate and define the toxicity of chemotherapy or radiotherapy.” | concepts[4] |
| concept | CTCAE — not defined in this paper's own words; Common Terminology Criteria for Adverse Events - the same instrument after the 2003 revision and rename — “In 2003, the US National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 2.0 [ 9 ] were revised and renamed the CTCAE version 3.0 [ 10 ]. This system has been used widely to evaluate and define the toxicity of chemotherapy or radiotherapy.” | concepts[5] |
| concept | JCOG PC criteria — not defined in this paper's own words; 72 named surgical adverse events with per-term grading, supplementing the Clavien-Dindo classification — “The JCOG PC criteria included 72 surgical AEs experienced commonly in surgical trials, including 17 gastroenterological complications, 13 infectious complications, six thoracic complications, and several other complications” | concepts[6] |
| concept | gastroenterological complications — not defined in this paper's own words; the largest block of the 72 terms - 17 of them — “The JCOG PC criteria included 72 surgical AEs experienced commonly in surgical trials, including 17 gastroenterological complications, 13 infectious complications, six thoracic complications, and several other complications” | concepts[7] |
| concept | Clavien-Dindo classification — not defined in this paper's own words; the framework this paper extends: ONE set of general rules applied uniformly to every surgical AE, deliberately not per-AE definitions — “Rather than providing specific grading criteria for each AE, the Clavien-Dindo classification provides broad-based but general criteria that can be used uniformly for all kinds of surgical AEs” | concepts[8] |
| concept | severity — not defined in this paper's own words; the graded quantity - named as severity, but every grade boundary in the scale is a KIND OF INTERVENTION, not a degree of suffering — “This revised version defines five grades of severity (Grade I, II, IIIa, IIIb, IVa, IVb, and V) and the suffix “d” (for “disability”) is used to denote any postoperative impairment” | concepts[9] |
| concept | intervention — not defined in this paper's own words; what the grades actually rank: none, pharmacological, procedure without general anaesthesia, procedure under general anaesthesia, ICU — “Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, or radiological interventions. Allowed therapeutic regimens include drugs such as antiemetics, antipyretics, analgesics, diuretics, electrolytes, and physiotherapy. This grade also includes wound infections opened at the bedside Requirement for pharmacological treatment with drugs other than those allowed for grade I complications Blood transfusions and total parenteral nutrition are also included Requirement for surgical, endoscopic or radiological intervention not under general anesthesia Requirement for surgical, endoscopic or radiological intervention under general anesthesia” | concepts[10] |
| concept | disability — not defined in this paper's own words; the suffix 'd' - complication still present at discharge; carried ALONGSIDE the grade rather than as a grade, because persistence does not sit on the intervention ladder — “If the patient suffers from a complication at the time of discharge, the suffix “d” (for “disability”) is added to the respective grade of complication. This label indicates the need for a follow-up to fully evaluate the complication” | concepts[11] |
| concept | adverse event — not defined in this paper's own words; the counted unit: Table 1 pairs a list of AE TERMS with a single PRINCIPLE OF GRADING, so a term and a grade are separate decisions — “Table 1 List of surgical adverse event (AE) terms and gradings Principle of grading” | concepts[12] |
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365 springeropen Surgery Today Surg Today PMC4848327 4848327 4848327 26289837 10.1007/s00595-015-1236-x Extended Clavien-Dindo classificationterm·mth of surgical complications: Japan Clinical Oncology Group postoperative complications criteria KatayamapersName Hiroshi 1 KurokawapersName Yukinori 2 NakamurapersName Kenichi 1 ItopersName Hiroyuki 3 KanemitsupersName Yukihide 4 MasudapersName Norikazu 5 TsubosapersName Yasuhiro 6 SatohpersName Toyomi 7 YokomizopersName Akira 8 FukudapersName Haruhiko 1 SasakopersName Mitsuru 9 ✉ 1 Japan Clinical Oncology Group Data Center/Operations Office, Center for Research Administration and Support, National Cancer Center, Tokyo, Japan 2 Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Suita, Japan 3 Department of Thoracic Surgery, Kanagawa Cancer Center, Yokohama, Japan 4 Colorectal Surgery Division, National Cancer Center Hospital, Tokyo, Japan 5 Department of Surgery, Breast Oncology, National Hospital Organization, Osaka National Hospital, Osaka, Japan 6 Division of Esophageal Surgery, Shizuoka Cancer Center, Shizuoka, Japan 7 Department of Obstetrics and Gynecology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan 8 Department of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan 9 Department of Surgery, Hyogo College of Medicine, Nishinomiya, Japan ✉ Corresponding author.
20 8 2015 46 668 668–685 12 5 2016 © The Author(s) 2015 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/ ), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. Abstract Purpose Prior to publication of the Clavien-Dindo classificationterm·mth in 2004, there were no grading definitions for surgical complications in either clinical practice or surgical trials. This report establishes supplementary criteria for this classification to standardize the evaluation of postoperative complications in clinical trials.
Methods The Japan Clinical Oncology Group (JCOG) commissioned a committee. Members from nine surgical study groups (gastric, esophageal, colorectal, lung, breast, gynecologic, urologic, bone and soft tissue, and brain) specified postoperative complications experienced commonly in their fields and defined more detailed grading criteria for each complication in accordance with the general grading rules of the Clavien-Dindo classificationterm·mth.
Results We listed 72 surgical complications experienced commonly in surgical trials, focusing on 17 gastroenterologic complications, 13 infectious complications, six thoracic complications, and several other complications. The grading criteria were defined simply and were optimized for surgical complications.
Conclusions The JCOG postoperative complications criteria (JCOG PC criteriaterm) aim to standardize the terms used to define adverse eventsterm (AEs) and provide detailed grading guidelines based on the Clavien-Dindo classificationterm·mth. We believe that the JCOG PC criteriaterm will allow for more precise comparisons of the frequency of postoperative complications among trials across many different surgical fields.
Keywords: JCOG postoperative complications criteria (JCOG PC criteriaterm), Clavien-Dindo classificationterm·mth, Postoperative complications status released display-pdf yes is-in-collection-domain yes is-olf no is-manuscript no is-preprint no is-journal-matter no is-scanned no is-retracted no Received 2015 Apr 24; Accepted 2015 Jun 14; Issue date 2016.
Introduction The evaluation of postoperative complications in surgical trials is as important as the assessment of toxicities in chemotherapy trials. Prior to the proposal of a therapy-oriented classification scheme, by Clavien PA et al. in 1992 [ 1 ], there were no accepted definitions for the grading of surgical complications in clinical practice. This framework proposed by Clavien et al. was not used widely, because there was no system for the grading of severityterm of surgical complications [ 2 ] and no uniform definition of these events. For instance, some surgeons included a body temperature greater than 38 °C on two consecutive days as being “high”, whereas others included intraoperative complications, postoperative complications (within 30 days), and late events such as dumping syndrome. Few randomized controlled trials (RCTs) [ 3 ] have used this classification system, with individual parochial definitions of surgical complications being used in most surgical RCTs [ 4 – 6 ].
In cancer clinical trials, adverse eventsterm (AEs) are evaluated in accordance with the Common Terminology Criteria for Adverse Eventsterm (CTCAEterm), which is far from exhaustive in terms of surgical complications; thus, some surgeons are not comfortable using grading definitions. The Clavien-Dindo classificationterm·mth, published in 2004 [ 7 ] defined a simple classification of postoperative complications, which has been adopted widely in clinical practice. Although this classification categorizes postoperative complications broadly into four major groups, it is often desirable to more clearly define the common AEs to avoid the use of different or less precise terms for the same AEs occurring in different clinical trials. More detailed grading criteria for common AEs would also be helpful for surgeons. Therefore, our aim was to establish supplementary criteria for the Clavien-Dindo classificationterm·mth to standardize the evaluation of postoperative complications.
Methods The Japan Clinical Oncology Group (JCOG) commissioned a committee to establish more precise criteria for the grading of surgical complications. The committee comprised members from nine JCOG study groups (gastric, esophageal, colorectal, lung, breast, gynecologic, urologic, bone and soft tissue, and brain) who have extensive experience with surgical trials. These groups established the JCOG postoperative complications criteria (JCOG PC criteriaterm). Members identified the postoperative complications experienced commonly in their fields and defined detailed grades for each complication in accordance with the general grading rules of the Clavien-Dindo classificationterm·mth. The JCOG PC criteriaterm were reviewed and approved by the JCOG Executive Committee and published on the JCOG website in October, 2011 (in Japanese) [ 8 ].
Results The JCOG PC criteriaterm included 72 surgical AEs experienced commonly in surgical trials, including 17 gastroenterological complicationsterm, 13 infectious complications, six thoracic complications, and several other complications (Table 1 ). If no applicable AE terms are found in the JCOG PC criteriaterm, ‘other (specify)term·def’ should be chosen. In such cases, the appropriate AE term should be used, and the overall grading should be performed in accordance with the general rules of the Clavien-Dindo classificationterm·mth. Because the grading definitions follow the general rules of the Clavien-Dindo classificationterm·mth, surgeons can use these original rules to grade AEs, and can also refer to the more detailed definitions in the JCOG PC criteriaterm if necessary. Table 2 lists the differences between CTCAEterm, the Clavien-Dindo classificationterm·mth, and the JCOG PC criteriaterm.
Table 1 List of surgical adverse eventterm (AE) terms and gradings Principle of grading I II IIIa IIIb IVa IVb V Supplemental explanation of suffix “d”
AE term Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, or radiological interventionsterm. Allowed therapeutic regimens include drugs such as antiemetics, antipyretics, analgesics, diuretics, electrolytes, and physiotherapy. This grade also includes wound infections opened at the bedside Requirement for pharmacological treatment with drugs other than those allowed for grade I complications Blood transfusions and total parenteral nutrition are also included Requirement for surgical, endoscopic or radiological interventionterm not under general anesthesia Requirement for surgical, endoscopic or radiological interventionterm under general anesthesia Life-threatening complications (including CNS complications)* requiring IC/ICU management. Single organ dysfunction (including dialysis) Life-threatening complications (including CNS complications)* requiring IC/ICU management. Multiple organ dysfunction Death of the patient If the patient suffers from a complication at the time of discharge, the suffix “d” (for “disabilityterm”) is added to the respective grade of complication. This label indicates the need for a follow-up to fully evaluate the complication Stroke Clinical observation only; interventionterm not indicated Medical management indicated (e.g., anticoagulant therapy) Radiological interventionterm without general anesthesia (e.g., intracerebrovascular treatment) Interventionterm under general anesthesia indicated (e.g., drainage, surgical clipping, cerebrovascular bypass, carotid endarterectomy) IC/ICU management indicated IC/ICU management indicated; associated with respiratory failure Death Persistent hemiplegia Recurrent laryngeal nerve palsy Clinical observation or diagnostic evaluation only; interventionterm not indicated Aspiration; medical management indicated (e.g., antibiotics) Severe aspiration; food intake almost impossible; medical interventionterm under local anesthesia indicated (e.g., vocal cord injection, tracheal puncture) Interventionterm under general anesthesia indicated (including tracheostomy under sedation) Mechanical ventilation indicated Sepsis or multiple organ failure Death Hoarseness, difficulty in speaking; communication through writing necessary; discharged with tracheostomy Upper extremity paresthesia Clinical observation only; interventionterm not indicated Medical management indicated Surgical interventionterm without general anesthesia indicated (e.g., nerve block) – – – – Persistent brachial paresthesia Paresthesia in resected part (Phantom pain) Clinical observation only; interventionterm not indicated Medical management indicated Surgical interventionterm without general anesthesia indicated (e.g., nerve block) – – – – Persistent phantom pain Ischemic heart disease Clinical observation or diagnostic evaluation only; interventionterm not indicated Medical management indicated (e.g., anticoagulant therapy) Cardiac catheterization indicated Interventionterm under general anesthesia indicated (coronary artery bypass) Heart failure associated with low cardiac output syndrome; IC/ICU management indicated Heart failure associated with low cardiac output syndrome and renal failure; IC/ICU management indicated Death Persistent heart failure following myocardial infarction Pericardial effusion Clinical observation or diagnostic evaluation only; interventionterm not indicated (drainage only through existing drainage tube) Medical management indicated Image-guided drain placement/paracentesis including drain replacement indicated Interventionterm under general anesthesia indicated (fenestration) Cardiac tamponade; IC/ICU management indicated Cardiac tamponade and renal failure; IC/ICU management indicated Death – Bradyarrhythmia Clinical observation or diagnostic evaluation only; interventionterm not indicated Medical management indicated (e.g., atropine, β agonists) Medical interventionterm under local anesthesia indicated (e.g., pacemaker implantation) – Heart failure associated with low cardiac output syndrome; IC/ICU management indicated Heart failure associated with low cardiac output syndrome and renal failure; IC/ICU management indicated Death – Supraventricular arrhythmia Clinical observation or diagnostic evaluation only; interventionterm not indicated Medical management indicated (e.g., antiarrhythmic drugs) Medical interventionterm under local anesthesia indicated (e.g., catheter ablation, synchronized cardioversion) – Heart failure associated with low cardiac output syndrome; IC/ICU management indicated Heart failure associated with low cardiac output syndrome and renal failure; IC/ICU management indicated Death – Ventricular arrhythmia Clinical observation or diagnostic evaluation only; interventionterm not indicated Medical management indicated (e.g., antiarrhythmic drugs) Medical interventionterm under local anesthesia indicated (e.g., catheter ablation, external defibrillator, pacemaker implantation) – Heart failure associated with low cardiac output syndrome; IC/ICU management indicated Heart failure associated with low cardiac output syndrome and renal failure; IC/ICU management indicated Death – Atelectasis/sputum excretion difficulty Clinical observation or diagnostic evaluation only; interventionterm not indicated, except for nebulizers, expectorants, or lung physiotherapy (e.g., postural drainage) Medical management indicated (e.g., antibiotics) Bronchoscopic aspiration or surgical interventionterm indicated (e.g., tracheal puncture) without general anesthesia Interventionterm under general anesthesia indicated (including tracheostomy under sedation) Mechanical ventilation indicated Sepsis or multiple organ failure Death Discharged with tracheostomy Tracheal fistula, bronchial fistula Clinical observation or diagnostic evaluation only; interventionterm not indicated – Procedure under local anesthesia indicated Interventionterm under general anesthesia indicated Mechanical ventilation indicated Sepsis or multiple organ failure Death Discharged with tube drainage, open drainage Pulmonary fistula Clinical observation or diagnostic evaluation only; interventionterm not indicated (drainage only through existing drainage tube) – Procedure under local anesthesia indicated (e.g., chest tube drainage, pleurodesis) including drain replacement indicated. Interventionterm under general anesthesia indicated (Closure for pleuroparenchymal defects, pleurodesis) Mechanical ventilation indicated Sepsis or multiple organ failure Death Discharged with tube drainage, open drainage Chylothorax Observation of chylous drainage fluid or thoracentesis fluid only (drainage only through existing drainage tube) Fat-restricted diet, intravenous nutrition indicated Image-guided drain placement/paracentesis including drain replacement indicated Interventionterm under general anesthesia indicated (e.g., thoracic duct ligation) – – Death Persistent respiratory distress, malnutrition Pleural effusion Clinical observation or diagnostic evaluation only; interventionterm not indicated (drainage only through existing drainage tube) Medical management indicated (e.g., diuretics) Image-guided drain placement/thoracentesis including drain replacement indicated Interventionterm under general anesthesia indicated Mechanical ventilation indicated Multiple organ failure Death Persistent respiratory distress Lung torsion – – – Interventionterm under general anesthesia indicated (e.g., detorsion, lobectomy) Mechanical ventilation indicated Sepsis or multiple organ failure Death – Ascites Clinical observation or diagnostic evaluation only; interventionterm not indicated (drainage only through existing drainage tube) Medical management indicated (e.g., diuretics) Image-guided drain placement/paracentesis including drain replacement indicated Interventionterm under general anesthesia indicated – – Death Persistent abdominal fullness Diarrhea Intestinal fluid excretion ≥2000 ml/day; interventionterm not indicated Intestinal fluid excretion ≥2000 ml/day associated with dehydration or electrolyte abnormality; intravenous fluids indicated – – At least one organ failure (e.g., pulmonary disorders requiring mechanical ventilation or nephropathy indicating dialysis) Sepsis or multiple organ failure Death Significant amount of persistent intestinal fluid excretion Dysphagia Clinical observation only; interventionterm not indicated Enteral/intravenous nutrition (Including TPN) indicated Medical interventionterm under local anesthesia indicated (e.g., tracheal puncture, endoscopic gastrostomy) Interventionterm under general anesthesia indicated – – Death Gastrostomy Intestinal fistula Clinical observation or diagnostic evaluation only; interventionterm not indicated (drainage only through existing drainage tube) Medical management indicated (e.g., antibiotics) Image-guided drain placement/paracentesis including drain replacement indicated Interventionterm under general anesthesia indicated (colostomy) At least one organ failure (e.g., pulmonary disorders requiring mechanical ventilation or renal disorders indicating dialysis) Sepsis or multiple organ failure Death Persistent enterocutaneous fistula Intestinal ischemia/necrosis Clinical observation or diagnostic evaluation only; interventionterm not indicated Medical management indicated (e.g., antibiotics) Radiological interventionterm/endoscopic/surgical interventionterm without general anesthesia indicated Interventionterm under general anesthesia indicated (e.g., intestinal resection) At least one organ failure (e.g., pulmonary disorders indicating mechanical ventilation or renal disorders indicating dialysis) Sepsis or multiple organ failure Death Home enteral/intravenous nutrition Gastric tube necrosis Observation of a small fistula with oral contrast study or drainage imaging (drainage only through existing drainage tube) Medical management (e.g., antibiotics), enteral/intravenous nutrition indicated Radiological interventionterm/endoscopic/elective surgical interventionterm without general anesthesia indicated, including drain replacement Interventionterm under general anesthesia indicated At least one organ failure (e.g., pulmonary disorders requiring mechanical ventilation or nephropathy indicating dialysis) Sepsis or multiple organ failure Death Reflux esophagitis Clinical observation or diagnostic evaluation only; interventionterm not indicated Medical management (e.g., PPI, pancreatic enzyme inactivators) or enteral/intravenous nutrition indicated – Interventionterm under general anesthesia indicated – – Death Persistent heartburn Ileusterm (paralytic) Clinical observation or diagnostic evaluation only; medical management not indicated except for laxatives and intravenous nutrition Medical management beyond laxatives, NG tube placement, or intravenous nutrition management indicated Nasoenteric tube placement Treatment for ileusterm under general anesthesia (with or without intestinal resection) Extensive intestinal necrosis, at least one organ failure (e.g., pulmonary disorders requiring mechanical ventilation or nephropathy indicating dialysis) Sepsis or multiple organ failure Death Home intravenous nutrition Pancreatic fistulaterm On or after postoperative day 3, drainage fluid amylase level ≥3 times the upper limit of institutional criteria, but interventionterm not indicated Medical management indicated (e.g., antibiotics), enteral/intravenous nutrition indicated Image-guided drain placement/paracentesis including drain replacement indicated Interventionterm under general anesthesia indicated At least one organ failure (e.g., pulmonary disorders requiring mechanical ventilation or nephropathy indicating dialysis) Sepsis or multiple organ failure Death Residual pancreatic pseudocyst on CT, occasional fever, or abdominal pain Intestinal obstruction Clinical observation or diagnostic evaluation only; medical management not indicated except for laxatives and intravenous nutrition Medical management beyond laxatives, NG tube placement, or intravenous nutrition management indicated Nasoenteric tube placement Treatment for ileusterm under general anesthesia (with or without intestinal resection) Extensive intestinal necrosis, at least one organ failure (e.g., pulmonary disorders requiring mechanical ventilation or nephropathy indicating dialysis) Sepsis or multiple organ failure Death Home intravenous nutrition Delayed gastric emptying Clinical observation or diagnostic evaluation only; interventionterm not indicated Medical management (e.g., peristalsis stimulating drugs), NG tube placement, enteral/intravenous nutrition indicated – Interventionterm under general anesthesia indicated – – Death Persistent postprandial nausea Dumping syndrome Clinical observation only; interventionterm not indicated Medical management indicated – Interventionterm under general anesthesia indicated – – Death Persistent dumping symptom Biliary fistula Clinical observation or diagnostic evaluation only; interventionterm not indicated (drainage only through existing drainage tube) Medical management indicated (e.g., antibiotics) Image-guided drain placement/paracentesis including drain replacement indicated Interventionterm under general anesthesia indicated (drainage) At least one organ failure (e.g., pulmonary disorders requiring mechanical ventilation or nephropathy indicating dialysis) Sepsis or multiple organ failure Death Residual pseudocyst on CT; occasional fever or abdominal pain Cholecystitis Clinical observation or diagnostic evaluation only; medical management not indicated except for cholagogues Medical management beyond cholagogues indicated Medical interventionterm under local anesthesia indicated (e.g., Percutaneous transhepatic gallbladder drainage) Interventionterm under general anesthesia indicated (cholecystectomy) At least one organ failure (e.g., pulmonary disorders requiring mechanical ventilation or nephropathy indicating dialysis) Sepsis or multiple organ failure Death Occasional fever or abdominal pain Gastrointestinal anastomotic leak Only small fistula observed on oral contrast study or drainage imaging (drainage only through existing drainage tube) Medical management (e.g., antibiotics) or enteral/intravenous nutrition (Including TPN) indicated Image-guided drain placement/paracentesis including wound opening or drain replacement indicated Interventionterm under general anesthesia indicated (e.g., suture, reanastomosis, bypass, drainage, colostomy) At least one organ failure (e.g., pulmonary disorders requiring mechanical ventilation or nephropathy indicating dialysis) Sepsis or multiple organ failure Death Home enteral/intravenous nutrition Ureteric injury Clinical observation or diagnostic evaluation only; interventionterm not indicated Medical management indicated (e.g., antibiotics) Transurethral ureteral stent insertion or percutaneous nephrostomy Interventionterm under general anesthesia indicated Acute renal failure, hemodialysis Sepsis or multiple organ failure Death Discharged with ureteral stent Urethral injury Foley catheter placement Medical management indicated (e.g., antibiotics) Interventionterm under local or lumbar anesthesia indicated (e.g., percutaneous cystostomy) Interventionterm under general anesthesia indicated At least one organ failure (e.g., pulmonary disorders requiring mechanical ventilation or nephropathy indicating dialysis) Sepsis or multiple organ failure Death Discharged with Foley catheter placement Postoperative hemorrhage Controllable with compression only Blood transfusion or medical management indicated Surgical hemostasis under local anesthesia or endoscopic and radiological interventionterm hemostasis indicated Interventionterm under general anesthesia indicated (hemostasis) Single organ failure; stepdown ICU/ICU care indicated Multiple organ failure; IC/ICU management indicated Death Persistent anemia Seroma (Accumulation of serous fluid) Bedside paracentesis only (drainage only through existing drainage tube) – Image-guided drain placement/paracentesis including drain replacement indicated Interventionterm under general anesthesia indicated At least one organ failure (e.g., pulmonary disorders requiring mechanical ventilation or nephropathy indicating dialysis) Sepsis or multiple organ failure Death Exudate leakage from wound, occasional fever and infection, discharged with drainage tube Uterine anastomotic leak Clinical or vaginal observation only; interventionterm not indicated Medical management indicated (e.g., antibiotics) – Interventionterm under general anesthesia indicated (resuturing) At least one organ failure (e.g., pulmonary disorders requiring mechanical ventilation or nephropathy indicating dialysis) Sepsis or multiple organ failure Death Persistent leakage from uterovaginal anastomosis due to suture failure (surgical union of two different anatomical structures) Abdominal incisional hernia Clinical observation only; interventionterm not indicated except for truss and NSAIDs Medical management beyond truss and NSAIDs indicated Medical interventionterm under local anesthesia indicated Interventionterm under general anesthesia indicated (mesh, fascial resuturing) Extensive intestinal necrosis, at least one organ failure (e.g., pulmonary disorders requiring mechanical ventilation or nephropathy indicating dialysis) Sepsis or multiple organ failure Death Intestinal prolapse upon increased intra-abdominal pressure Wound dehiscence Clinical observation only; interventionterm not indicated except for wound irrigation Medical management indicated (e.g., antibiotics) Medical interventionterm under local anesthesia indicated (e.g., resuturing) Interventionterm under general anesthesia indicated (e.g., resuturing) Extensive intestinal necrosis, at least one organ failure (e.g., pulmonary disorders requiring mechanical ventilation or nephropathy indicating dialysis) Sepsis or multiple organ failure Death Discharged with significant wound dehiscence Gastrointestinal anastomotic stenosis Clinical observation or diagnostic evaluation only; interventionterm not indicated Enteral/intravenous nutrition (Including TPN) indicated Balloon dilatation, stenting, magnetic compression anastomosis Interventionterm under general anesthesia indicated (e.g., reanastomosis, bypass) – – Death Frequent outpatient endoscopic dilatation Intraabdominal abscess Clinical observation or diagnostic evaluation only; interventionterm not indicated Medical management indicated (e.g., antibiotics) Image-guided drain placement/paracentesis including drain replacement indicated Interventionterm under general anesthesia indicated (drainage) At least one organ failure (e.g., pulmonary disorders requiring mechanical ventilation or nephropathy indicating dialysis) Sepsis or multiple organ failure Death Residual abscess on CT, occasional fever or abdominal pain Pelvic abscess Clinical observation or diagnostic evaluation only; interventionterm not indicated Medical management indicated (e.g., antibiotics) Image-guided drain placement/paracentesis including drain replacement indicated Interventionterm under general anesthesia indicated (drainage) At least one organ failure (e.g., pulmonary disorders requiring mechanical ventilation or nephropathy indicating dialysis) Sepsis or multiple organ failure Death Residual abscess on CT, occasional fever or abdominal pain Pneumonia Clinical observation or diagnostic evaluation only; interventionterm not indicated except for nebulizers, expectorants, or lung physiotherapy (e.g., postural drainage) Medical management indicated (e.g., antibiotics) Bronchoscopic aspiration, tracheal puncture Tracheostomy under general anesthesia/sedation or mechanical ventilation Mechanical ventilation indicated Sepsis or multiple organ failure Death Persistent respiratory distress, occasional fever Mediastinitis Clinical observation or diagnostic evaluation only; interventionterm not indicated Medical management indicated (e.g., antibiotics) Image-guided drain placement/paracentesis including drain replacement indicated Interventionterm under general anesthesia indicated (drainage) At least one organ failure (e.g., pulmonary disorders requiring mechanical ventilation or nephropathy indicating dialysis) Sepsis or multiple organ failure Death Residual abscess on CT images, occasional fever or abdominal pain Pyothorax Clinical observation or diagnostic evaluation only; interventionterm not indicated Medical management indicated (e.g., antibiotics) Image-guided drain placement/paracentesis including drain replacement indicated Interventionterm under general anesthesia indicated (drainage) At least one organ failure (e.g., pulmonary disorders requiring mechanical ventilation or nephropathy indicating dialysis) Sepsis or multiple organ failure Death Residual abscess on CT images or discharged with tube drainage, open drainage Lower extremity lymphangitis (Lymph node infection) Clinical observation or diagnostic evaluation only; interventionterm not indicated Medical management indicated (e.g., antibiotics) Medical interventionterm under local anesthesia indicated (lymphatic anastomosis) Interventionterm under general anesthesia indicated (lymphatic anastomosis) At least one organ failure (e.g., pulmonary disorders requiring mechanical ventilation or nephropathy indicating dialysis) Sepsis or multiple organ failure – Persistent edema Infected lymphocele (Retroperitoneal abscess) Clinical observation or diagnostic evaluation only; interventionterm not indicated Medical management indicated (e.g., antibiotics) Drainage under local anesthesia or without anesthesia indicated Interventionterm under general anesthesia indicated (incision and drainage) At least one organ failure (e.g., pulmonary disorders requiring mechanical ventilation or nephropathy indicating dialysis) Sepsis or multiple organ failure Death Residual abscess on imaging study, occasional fever or abdominal pain Infectious cervicitis Clinical or vaginal observation only; interventionterm not indicated Medical management indicated (e.g., antibiotics) Drainage under local anesthesia or without anesthesia indicated Interventionterm under general anesthesia indicated (drainage, hysterectomy) At least one organ failure (e.g., pulmonary disorders requiring mechanical ventilation or nephropathy indicating dialysis) Sepsis or multiple organ failure Death Persistent infected vaginal discharge Uterine infection Clinical observation or diagnostic evaluation only; interventionterm not indicated Medical management indicated (e.g., antibiotics) Dilation and curettage under local anesthesia or without anesthesia indicated Interventionterm under general anesthesia indicated (drainage, hysterectomy) At least one organ failure (e.g., pulmonary disorders requiring mechanical ventilation or nephropathy indicating dialysis) Sepsis or multiple organ failure Death Residual abscess on imaging study, occasional fever or abdominal pain Ovarian infection Clinical observation or diagnostic evaluation only; interventionterm not indicated Medical management indicated (e.g., antibiotics) Paracentesis drainage under local anesthesia indicated Interventionterm under general anesthesia indicated (drainage, oophorectomy) At least one organ failure (e.g., pulmonary disorders requiring mechanical ventilation or nephropathy indicating dialysis) Sepsis or multiple organ failure Death Residual abscess on imaging study, occasional fever or abdominal pain Vulval infection Clinical observation or diagnostic evaluation only; interventionterm not indicated Medical management indicated (e.g., antibiotics) Paracentesis drainage under local anesthesia indicated Interventionterm under general anesthesia indicated (drainage, skin flap, or musculocutaneous flap) At least one organ failure (e.g., pulmonary disorders requiring mechanical ventilation or nephropathy indicating dialysis) Sepsis or multiple organ failure Death Residual abscess on imaging study, occasional fever or abdominal pain Wound infection Clinical observation or diagnostic evaluation only; interventionterm not indicated, except for wound opening and wound irrigation at the bedside Medical management indicated (e.g., antibiotics) Medical interventionterm under local anesthesia indicated (e.g., drainage) Interventionterm under general anesthesia indicated (e.g., drainage, resuturing) At least one organ failure (e.g., pulmonary disorders requiring mechanical ventilation or nephropathy indicating dialysis) Sepsis or multiple organ failure Death Continued outpatient irrigation Implant infection Clinical observation or diagnostic evaluation only; interventionterm not indicated Medical management indicated (e.g., antibiotics) Medical interventionterm under local anesthesia indicated (e.g., incision and drainage, implant removal) Interventionterm under general anesthesia indicated (implant removal) At least one organ failure (e.g., pulmonary disorders requiring mechanical ventilation or nephropathy indicating dialysis) Sepsis or multiple organ failure Death Discharged with drainage tube placement; persistent infection Bladder injury Foley catheter placement indicated Medical management indicated (e.g., antibiotics) – Interventionterm under general anesthesia indicated At least one organ failure (e.g., pulmonary disorders requiring mechanical ventilation or nephropathy indicating dialysis) Sepsis or multiple organ failure Death Discharged with Foley catheter placement Urinary incontinence Intermittent catheterization or Foley catheter placement indicated Medical management indicated (e.g., anticholinergics) Interventionterm under local or lumbar anesthesia indicated (e.g., clamp, collagen injection) Interventionterm under general anesthesia indicated (e.g., artificial urinary sphincter) Acute renal failure, hemodialysis Sepsis or multiple organ failure Death Persistent condition requiring Intermittent catheterization; Discharged with Foley catheter placement Residual urine/Urinary retention Intermittent catheterization or Foley catheter placement indicated Medical management indicated (e.g., cholinergics) Interventionterm under local or lumbar anesthesia indicated (e.g., endoscopic treatment, urethral dilatation) Interventionterm under general anesthesia indicated (e.g., fistula closure) Acute renal failure, hemodialysis Sepsis or multiple organ failure Death Persistent condition requiring intermittent catheterization; Discharged with Foley catheter placement Dyspareunia Discomfort associated with vaginal penetration; interventionterm not indicated Estrogen administration indicated Medical interventionterm under local anesthesia indicated Interventionterm under general anesthesia indicated – – – Persistent pain associated with sexual intercourse, persistent dyspareunia Erectile dysfunction Erectile dysfunction; interventionterm not indicated, except for external vacuum device for managing erectile dysfunction Medical management indicated (e.g., Phosphodiesterase 5 inhibitors or intracavernosal injection of vasoactive agonists) Interventionterm under local or lumbar anesthesia indicated Interventionterm under general anesthesia indicated (e.g., penile prosthesis) – – – Persistent erectile dysfunction Cervical atresia (uterine atresia) Clinical or vaginal observation only; interventionterm not indicated Associated with dysmenorrhea; medical management indicated (e.g., analgesics) Bougienage of cervical duct with or without local anesthesia indicated Interventionterm under general anesthesia indicated (cervical dilatation) – – – Persistent stenosis of the cervical os Vaginal fistula Clinical or vaginal observation only; interventionterm not indicated Medical management indicated (e.g., antibiotics) – Interventionterm under general anesthesia indicated (vaginal fistula closure, colostomy) At least one organ failure (e.g., pulmonary disorders requiring mechanical ventilation or nephropathy indicating dialysis) Sepsis or multiple organ failure Death Persistent leakage from vagina Ovarian deficiency syndrome Clinical observation or diagnostic evaluation only; interventionterm not indicated Medical management indicated (e.g., hormone replacement therapy) – – – – Death Hot flash requiring continued hormone replacement therapy, depression requiring continued psychiatric care Cervical chylous leakage Observation of chylous drainage fluid or paracentesis fluid only; interventionterm not indicated (drainage only through existing drainage tube) Fat-restricted diet, intravenous nutrition indicated Image-guided drain placement/paracentesis including drain replacement indicated. Interventionterm under general anesthesia indicated – – Death Persistent sensation of pressure in the neck Serous leakage Clinical observation only; interventionterm not indicated (drainage only through existing drainage tube) Medical management indicated (e.g., antibiotics) Image-guided drain placement/paracentesis including drain replacement indicated Interventionterm under general anesthesia indicated At least one organ failure (e.g., pulmonary disorders requiring mechanical ventilation or nephropathy indicating dialysis) Sepsis or multiple organ failure Death Exudate leakage from the wound, occasional fever and infection, discharged with drainage tube Chylous ascites Observation of chylous drainage fluid or paracentesis fluid only; interventionterm not indicated (drainage only through existing drainage tube) Fat-restricted diet, intravenous nutrition indicated Image-guided drain placement/paracentesis including drain replacement indicated Interventionterm under general anesthesia indicated – – Death Persistent abdominal fullness Subcutaneous phlebitis (Mondor disease) Clinical observation or diagnostic evaluation only; interventionterm not indicated except for NSAIDs Opioid administration, or treatment by pain control specialist indicated Medical interventionterm under local anesthesia indicated Interventionterm under general anesthesia indicated – – – Surgical site subcutaneous phlebitis; cord-like mass Thrombosis/embolism Clinical observation or diagnostic evaluation only; interventionterm not indicated Medical management indicated (e.g., anticoagulants) Invasive treatment indicated (e.g., thrombus ablation via catheter, IVC filter) Interventionterm under general anesthesia indicated (pulmonary artery thrombectomy) Single organ failure caused by thrombi (e.g., lung, brain, heart) Multiple organ failure caused by thrombi (e.g., lung, brain, heart) Death Dyspnea following pulmonary infarction, paralysis following cerebral infarction Restricted shoulder joint range of motion Clinical observation only; interventionterm not indicated except for NSAIDs Opioid administration, or treatment by pain control specialist indicated Surgical interventionterm without general anesthesia indicated (e.g., nerve block) Interventionterm under general anesthesia indicated – – – Continued restriction in the range of motion of the shoulder joint Fat necrosis Clinical observation or diagnostic evaluation only; interventionterm not indicated except for wound opening and wound irrigation at the bedside Medical management indicated (e.g., antibiotics) Medical interventionterm under local anesthesia indicated (e.g., incision and drainage) Interventionterm under general anesthesia indicated At least one organ failure (e.g., pulmonary disorders requiring mechanical ventilation or nephropathy indicating dialysis) Sepsis or multiple organ failure Death Wound fat necrosis, occasional cicatrization, fever or infection Skin necrosis (flap necrosis) Clinical observation or diagnostic evaluation only; interventionterm not indicated Medical management indicated (e.g., antibiotics) Medical interventionterm under local anesthesia indicated (e.g., debridement, skin grafting) Interventionterm under general anesthesia indicated (skin grafting) At least one organ failure (e.g., pulmonary disorders requiring mechanical ventilation or nephropathy indicating dialysis) Sepsis or multiple organ failure Death Insufficient epithelialization, persistent infection Subcutaneous emphysema Clinical observation or diagnostic evaluation only; interventionterm not indicated except for subcutaneous puncture and compression with breast band at the bedside – Radiological interventionterm treatment without general anesthesia indicated (e.g., subcutaneous drain insertion) Interventionterm under general anesthesia indicated – – – Discharged with subcutaneous air accumulation Upper extremity edema Interventionterm not indicated except for lymphatic massage and elastic stockings Medical management indicated (e.g., diuretics) Interventionterm under local anesthesia indicated (lymphatic anastomosis) Interventionterm under general anesthesia indicated (lymphatic anastomosis) – – – Continued elastic stocking use Lower extremity lymphedema (edema of the extremities, lymphedema, localized edema) Interventionterm not indicated except for lymphatic massage and elastic stockings Medical management indicated (e.g., diuretics) Interventionterm under local anesthesia indicated (lymphatic anastomosis) Interventionterm under general anesthesia indicated (lymphatic anastomosis) – – – Continued elastic stocking use Obturator/femoral neuropathy (Gait disturbance) Interventionterm not indicated except for walking aid and rehabilitation Medical management indicated (e.g., vitamins) – Interventionterm under general anesthesia indicated (e.g., nerve suture) – – – Persistent restriction in lower extremity adduction Wound pain Clinical observation only; interventionterm not indicated except for NSAIDs Opioid administration, or treatment by pain control specialist indicated Surgical interventionterm indicated (e.g., nerve block) – – – – Home pain control Others (No AE term) Deviation from normal postoperative course. Medication, surgical interventionterm, endoscopic treatment, or radiological interventionterm treatment not indicated Treatment with antiemetics, antipyretics, analgesics, or diuretics; electrolyte replenishment; or physical therapy is not included in this category (even if these treatments are indicated, the condition is categorized as Grade I); open wound infection at the bedside is Grade I Medication indicated except for antiemetics, antipyretics, analgesics, and diuretics Cases requiring blood transfusion or intravenous hyperalimentation are included Surgical, endoscopic, or radiological interventionterm treatment indicated (without general anesthesia) Surgical, endoscopic, radiological interventionterm treatment indicated (interventionterm under general anesthesia) IC/ICU management indicated; life-threatening complications (including complications in the central nervous system) AND single organ failure (including dialysis) IC/ICU management indicated; life-threatening complications (including complications in the central nervous system) AND multiple organ failure Death IC intermediate care, ICU intensive care unit, TPN total parenteral nutrition, PPI proton pump inhibitor, NG tube nasogastric tube, CT computed tomography Table 2 Characteristics of the three criteria CTCAEterm ver4.0 Clavien-Dindo classificationterm·mth JCOG PC criteriaterm AE terms Specified Not specified Specified Grading definitions Defined for each AE Single common definition for all AEs Defined for each AE (following the general definition of the Clavien-Dindo classificationterm·mth) Discussion Until Clavien PA et al. published their original classification in 1992, there were no established criteria or framework available to standardize surgical complications in surgical trials. In 2003, the US National Cancer Institute-Common Toxicity Criteria (NCI-CTCterm) version 2.0 [ 9 ] were revised and renamed the CTCAEterm version 3.0 [ 10 ]. This system has been used widely to evaluate and define the toxicity of chemotherapy or radiotherapy. While terms and definitions for AEs occurring as a result of intraoperative and postoperative complications were not included in the NCI-CTCterm version 2.0, some surgical AE terms were incorporated in the CTCAEterm version 3.0. Nevertheless, the CTCAEterm version 3.0 failed to include many surgical complications and surgeons were frequently unable to objectively classify complications using its grading definitions.
In 2009, the CTCAEterm version 4.0 [ 11 ] was released, with considerably more surgical AE terms, but several common surgical complications were still not included. For example, intra-abdominal abscess, pyothorax, delayed gastric emptying, and lung torsion were not listed as AE terms. Moreover, grading definitions were not clinically optimized for some surgical AEs. For example, the grading definition of pancreatic fistulaterm in this version of the CTCAEterm is suitable for pancreatitisterm, but not for pancreatic fistulaterm after pancreatectomy. Such inappropriate definitions have made surgeons reluctant to use the CTCAEterm version 4.0 in surgical trials.
In 2004, the Clavien-Dindo classificationterm·mth was modified to allow for the grading of life-threatening complications and long-term disabilityterm caused by a complication. This revised version defines five grades of severityterm (Grade I, II, IIIa, IIIb, IVa, IVb, and V) and the suffix “d” (for “disabilityterm”) is used to denote any postoperative impairment [ 7 ]. This refined Clavien-Dindo classificationterm·mth has been used increasingly in clinical practice and also in clinical trials involving surgical procedures, because it is simple, reproducible, and flexible [ 12 ]. Rather than providing specific grading criteria for each AE, the Clavien-Dindo classificationterm·mth provides broad-based but general criteria that can be used uniformly for all kinds of surgical AEs. However, several issues have emerged since this classification became more widely used. One controversial issue is that AE terms are not well defined and different AE terms designate the same AEs in different clinical trials. For example, when intestinal obstruction occurs, some investigators could report this AE as “ileusterm”, but others refer to it as “small bowel obstructionterm” or “colon obstruction”. Under such circumstances, the incidence of this AE cannot be counted accurately. A second issue is that only general grading criteria are defined and therefore, grading can be difficult in some cases and subject to bias by the grader. For example, primary non-operative treatment for intestinal obstruction is gastroenteric tube decompression. Nasogastric tube or nasoenteric tube is utilized depending on the severityterm, but the original Clavien-Dindo classificationterm·mth does not define what grading should be applied for any type of gastroenteric tube placement for decompression.
The JCOG PC criteriaterm were established to address these issues. The advantages of the JCOG PC criteriaterm are as follows: First, commonly experienced surgical AEs are specified and listed. To compare precisely the frequency of surgical complications between studies, use of the common AE terms specified in the JCOG PC criteriaterm is recommended. Second, grading definitions are straightforward and optimized for surgical complications. With these advantages, the JCOG recommends that the JCOG PC criteriaterm be used to supplement the Clavien-Dindo classificationterm·mth, while maintaining the overall Clavien-Dindo classificationterm·mth. In JCOG, some disease-oriented subgroups are conducting clinical trials including surgery and using both the CTCAEterm and JCOG PC criteriaterm to evaluate postoperative complications. After these trials are completed, we will evaluate the concordance between the grading by the CTCAEterm and that by the JCOG PC criteriaterm. We also plan to explore the advantages and disadvantages of the JCOG PC criteriaterm.
The JCOG PC criteriaterm have some limitations. First, these AE terms were chosen somewhat arbitrarily, but by experienced surgeons, and specific grading was decided based on the opinions and experience of our committee members. A second limitation of the JCOG PC criteriaterm is that they do not include intraoperative complications. Our intent was to further define and clarify the criteria of the Clavien-Dindo classificationterm·mth and we considered that incorporating intraoperative complications would deviate too much from the original concept. Another common classification may be required to define and grade intraoperative complications. A third limitation is that all descriptions in the Clavien-Dindo classificationterm·mth pertain to early postoperativeterm·def complications. Here, ‘early postoperativeterm·def’ generally indicates the time from surgery to the first hospital discharge, but in theory, the Clavien-Dindo classificationterm·mth can be applied broadly to late postoperative complications after hospital discharge. Within this context, the JCOG PC criteriaterm are mainly intended to be used for early postoperativeterm·def complications, but they can also be used after hospital discharge, although would require more definitions and AEs.
In conclusion, the goals of the JCOG PC criteriaterm are to standardize the AE terms used for early postoperativeterm·def complications by providing more detailed grading guidelines based on the Clavien-Dindo classificationterm·mth. We suggest that researchers use the JCOG PC criteriaterm in every surgical trial to allow for precise comparison of the frequency of surgical complications among trials.
Acknowledgments This project was supported by the National Cancer Center Research and Development Fund (23-A-16, 26-A-4). We thank Hiroaki Hiraga and Yasuji Miyakita for their specialist advice.
Compliance with ethical standards Conflict of interest Hiroshi KatayamapersName and his coauthors declare no conflicts of interest regarding this research.