Extended Clavien-Dindo classification of surgical complications: Japan Clinical Oncology Group postoperative complications criteria

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Abstract

Purpose

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. 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 classification.

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 criteria) aim to standardize the terms used to define adverse events (AEs) and provide detailed grading guidelines based on the Clavien-Dindo classification. We believe that the JCOG PC criteria will allow for more precise comparisons of the frequency of postoperative complications among trials across many different surgical fields.

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Most cited references 4

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Short-term endpoints of conventional versus laparoscopic-assisted surgery in patients with colorectal cancer (MRC CLASICC trial): multicentre, randomised controlled trial.

Pierre Guillou, Philip Quirke, Helen Thorpe … (2005)

Laparoscopic-assisted surgery for colorectal cancer has been widely adopted without data from large-scale randomised trials to support its use. We compared short-term endpoints of conventional versus laparoscopic-assisted surgery in patients with colorectal cancer to predict long-term outcomes. Between July, 1996, and July, 2002, we undertook a multicentre, randomised clinical trial in 794 patients with colorectal cancer from 27 UK centres. Patients were allocated to receive laparoscopic-assisted (n=526) or open surgery (n=268). Primary short-term endpoints were positivity rates of circumferential and longitudinal resection margins, proportion of Dukes' C2 tumours, and in-hospital mortality. Analysis was by intention to treat. This trial has been assigned the International Standard Randomised Controlled Trial Number ISRCTN74883561. Six patients (two [open], four [laparoscopic]) had no surgery, and 23 had missing surgical data (nine, 14). 253 and 484 patients actually received open and laparoscopic-assisted treatment, respectively. 143 (29%) patients underwent conversion from laparoscopic to open surgery. Proportion of Dukes' C2 tumours did not differ between treatments (18 [7%] patients, open vs 34 [6%], laparoscopic; difference -0.3%, 95% CI -3.9 to 3.4%, p=0.89), and neither did in-hospital mortality (13 [5%] vs 21 [4%]; -0.9%, -3.9 to 2.2%, p=0.57). Apart from patients undergoing laparoscopic anterior resection for rectal cancer, rates of positive resection margins were similar between treatment groups. Patients with converted treatment had raised complication rates. Laparoscopic-assisted surgery for cancer of the colon is as effective as open surgery in the short term and is likely to produce similar long-term outcomes. However, impaired short-term outcomes after laparoscopic-assisted anterior resection for cancer of the rectum do not yet justify its routine use.

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Proposed classification of complications of surgery with examples of utility in cholecystectomy.

P A Clavien, J. Sanabria, S Strasberg (1992)

Lack of uniform reporting of negative outcomes makes interpretation of surgical literature difficult. We attempt to define and classify negative outcomes by differentiating complications, sequelae, and failures. Complications and sequelae result from procedures, adding new problems to the underlying disease. However, complications are unexpected events not intrinsic to the procedure, whereas sequelae are inherent to the procedure. Failures are events in which the purpose of the procedure is not fulfilled. We propose a classification of complications based on four grades: Grade I complications are alterations from the ideal postoperative course, non-life-threatening, and with no lasting disability. Complications of this grade necessitate only bedside procedures and do not significantly extend hospital stay. Grade II complications are potentially life-threatening but without residual disability. Within grade II complications a subdivision is made according to the requirement for invasive procedures. Grade III complications are those with residual disability, including organ resection or persistence of life-threatening conditions. Finally, grade IV complications are deaths as a result of complications. To illustrate the relevance of the classification, we reviewed 650 cases of elective cholecystectomy. Risk factors for development of complications were determined, and the classification was also used to analyze the value of a modified APACHE II as a preoperative prognostic score. Both supported the relevance of the proposed classification. The advantages of such a classification are (1) increased uniformity in reporting results, (2) the ability to compare results of two distinct time periods in a single center, (3) the ability to compare results of surgery between different centers, (4) the ability to compare results of surgical versus nonsurgical measures, (5) the ability to perform adequate metaanalysis, (6) the ability to identify objective preoperative risk factors, and (7) the ability to establish preoperative prognostic scores.

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Gastric cancer surgery: morbidity and mortality results from a prospective randomized controlled trial comparing D2 and extended para-aortic lymphadenectomy--Japan Clinical Oncology Group study 9501.

Yoshitaka Yamamura, K Okajima, Seiichiro Yamamoto … (2004)

Radical gastrectomy with regional lymphadenectomy is the only curative treatment option for gastric cancer. The extent of lymphadenectomy, however, is controversial. The two European randomized trials only reported an increase in operative morbidity and mortality, but failed to show survival benefit, in the D2 lymphadenectomy group. We conducted a randomized controlled trial to compare the Japanese standard D2 and D2 + para-aortic nodal dissection. Only experienced surgeons in both procedures from 24 Japanese institutions participated in the study. Patients with potentially curable gastric adenocarcinoma (T2-subserosa, T3, or T4) who were surgically fit were intraoperatively randomized. Postoperative morbidity and hospital mortality were recorded prospectively in a fixed format and were compared between the two groups in this study. A total of 523 patients were randomized between July 1995 and April 2001. Postoperative complications were reported in 24.5% of all patients. Although the morbidity for the extended surgery group (28.1%) was slightly higher than the standard group (20.9%), there was no difference in the incidence of four major complications (anastomotic leak, pancreatic fistula, abdominal abscess, pneumonia) between the two groups. Hospital mortality was reported at 0.80%: one patient in each group died of operative complications, while one from each group died of rapid progressive cancer while inpatient. Specialized surgeons could safely perform gastrectomy with D2 lymphadenectomy in patients with low operative risks. Para-aortic lymphadenectomy could be added without increasing major surgical complications in this setting.

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Author and article information

Contributors

Mitsuru Sasako: +81-798-45-6767 , msasako@hyo-med.ac.jp

Journal

Journal ID (nlm-ta): Surg Today

Journal ID (iso-abbrev): Surg. Today

Title: Surgery Today

Publisher: Springer Japan (Tokyo )

ISSN (Print): 0941-1291

ISSN (Electronic): 1436-2813

Publication date (Electronic): 20 August 2015

Publication date PMC-release: 20 August 2015

Publication date (Print): 2016

Volume: 46

Pages: 668-685

Affiliations

[ ]Japan Clinical Oncology Group Data Center/Operations Office, Center for Research Administration and Support, National Cancer Center, Tokyo, Japan

[ ]Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Suita, Japan

[ ]Department of Thoracic Surgery, Kanagawa Cancer Center, Yokohama, Japan

[ ]Colorectal Surgery Division, National Cancer Center Hospital, Tokyo, Japan

[ ]Department of Surgery, Breast Oncology, National Hospital Organization, Osaka National Hospital, Osaka, Japan

[ ]Division of Esophageal Surgery, Shizuoka Cancer Center, Shizuoka, Japan

[ ]Department of Obstetrics and Gynecology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan

[ ]Department of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan

[ ]Department of Surgery, Hyogo College of Medicine, Nishinomiya, Japan

Article

Publisher ID: 1236

DOI: 10.1007/s00595-015-1236-x

PMC ID: 4848327

PubMed ID: 26289837

SO-VID: cefc76d7-33ae-464e-a52c-3985d15ceb0c

License:

Open AccessThis 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.

History

Date received : 24 April 2015

Date accepted : 14 June 2015

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ScienceOpen disciplines: Surgery

Keywords: jcog postoperative complications criteria (jcog pc criteria),clavien-dindo classification,postoperative complications

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ScienceOpen disciplines: Surgery

Keywords: jcog postoperative complications criteria (jcog pc criteria), clavien-dindo classification, postoperative complications

Extended Clavien-Dindo classification of surgical complications: Japan Clinical Oncology Group postoperative complications criteria

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Karger: Oncology

Most cited references 4

Short-term endpoints of conventional versus laparoscopic-assisted surgery in patients with colorectal cancer (MRC CLASICC trial): multicentre, randomised controlled trial.

Proposed classification of complications of surgery with examples of utility in cholecystectomy.

Gastric cancer surgery: morbidity and mortality results from a prospective randomized controlled trial comparing D2 and extended para-aortic lymphadenectomy--Japan Clinical Oncology Group study 9501.

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