Institutional variation in survival and morbidity in laparoscopic surgery for colon cancer: From the data of a randomized controlled trial comparing open and laparoscopic surgery (JCOG0404).
colon cancer
institutional variation
laparoscopic surgery
open surgery
randomized controlled trial
Journal
Annals of gastroenterological surgery
ISSN: 2475-0328
Titre abrégé: Ann Gastroenterol Surg
Pays: Japan
ID NLM: 101718062
Informations de publication
Date de publication:
Nov 2021
Nov 2021
Historique:
received:
01
04
2021
revised:
14
06
2021
accepted:
21
06
2021
entrez:
10
11
2021
pubmed:
11
11
2021
medline:
11
11
2021
Statut:
epublish
Résumé
Institutional variation in outcomes is a key factor to ascertain the generalizability of results and reliability of the clinical trial. This study evaluated institutional variation in survival and postoperative complications using data from JCOG0404 comparing laparoscopic colectomy (LAP) with open colectomy (OP). Institutions with fewer than 10 registered patients were excluded from this analysis. Institutional variation was evaluated in terms of early postoperative complications, overall survival, and relapse-free survival and estimated using a mixed-effect model with institution as a random effect after adjusting for background factors. This analysis included 1028 patients in the safety analysis and 1040 patients in the efficacy analysis from 26 institutions. In the safety analysis, there was no variation in grades 3-4 early postoperative complications (in OP, median 6.3% [range 6.3%-6.3%]; in LAP, median 2.6% [range 2.6%-2.6%]), but some variation in grades 1-4 early postoperative complications was observed (in OP, median 20.8% [range 13.2%-31.8%]; in LAP, median 11.9% [range 7.2%-28.7%]), and that in grades 2-4 was observed only in LAP (median 8.8% [range 4.7%-24.0%]; in OP, median 12.7% [range 12.7%-12.7%]). Two specific institutions showed especially high incidences of postoperative complications in LAP. In the efficacy analysis, there was no institutional variation in OP, although a certain variation was observed in LAP. Some institutional variations in safety and efficacy were observed, although only in LAP. We conclude that a qualification system, including training and education, is needed when new surgical techniques such as laparoscopic surgery are introduced in clinical practice.
Sections du résumé
BACKGROUND
BACKGROUND
Institutional variation in outcomes is a key factor to ascertain the generalizability of results and reliability of the clinical trial. This study evaluated institutional variation in survival and postoperative complications using data from JCOG0404 comparing laparoscopic colectomy (LAP) with open colectomy (OP).
METHODS
METHODS
Institutions with fewer than 10 registered patients were excluded from this analysis. Institutional variation was evaluated in terms of early postoperative complications, overall survival, and relapse-free survival and estimated using a mixed-effect model with institution as a random effect after adjusting for background factors.
RESULTS
RESULTS
This analysis included 1028 patients in the safety analysis and 1040 patients in the efficacy analysis from 26 institutions. In the safety analysis, there was no variation in grades 3-4 early postoperative complications (in OP, median 6.3% [range 6.3%-6.3%]; in LAP, median 2.6% [range 2.6%-2.6%]), but some variation in grades 1-4 early postoperative complications was observed (in OP, median 20.8% [range 13.2%-31.8%]; in LAP, median 11.9% [range 7.2%-28.7%]), and that in grades 2-4 was observed only in LAP (median 8.8% [range 4.7%-24.0%]; in OP, median 12.7% [range 12.7%-12.7%]). Two specific institutions showed especially high incidences of postoperative complications in LAP. In the efficacy analysis, there was no institutional variation in OP, although a certain variation was observed in LAP.
CONCLUSIONS
CONCLUSIONS
Some institutional variations in safety and efficacy were observed, although only in LAP. We conclude that a qualification system, including training and education, is needed when new surgical techniques such as laparoscopic surgery are introduced in clinical practice.
Identifiants
pubmed: 34755014
doi: 10.1002/ags3.12484
pii: AGS312484
pmc: PMC8560602
doi:
Types de publication
Journal Article
Langues
eng
Pagination
823-831Informations de copyright
© 2021 The Authors. Annals of Gastroenterological Surgery published by John Wiley & Sons Australia, Ltd on behalf of The Japanese Society of Gastroenterology.
Déclaration de conflit d'intérêts
Conflict of Interest: Y.K. reports grants from Johnson & Johnson and Medtronic, and a lecture fee from Johnson & Johnson. M.O. reports grants from the Ministry of Health, Labour and Welfare of Japan; lecture fees from Chugai Pharmaceutical Co., Ltd., Taiho Pharma, Johnson & Johnson K. K., Medicaroid Corporation, Eli Lily Japan K. K., Olympus Corporation, and Covidien Japan Inc The other authors declare no conflicts of interest.
Références
Jpn J Clin Oncol. 2005 Aug;35(8):475-7
pubmed: 16006574
BMC Surg. 2019 Jul 11;19(1):90
pubmed: 31296194
BMJ. 2002 Jun 15;324(7351):1448-51
pubmed: 12065273
Lancet Oncol. 2010 May;11(5):439-49
pubmed: 20409751
Ann Surg. 2008 Nov;248(5):746-50
pubmed: 18948801
Lancet Oncol. 2009 Jan;10(1):44-52
pubmed: 19071061
Br J Surg. 2015 Aug;102(9):1088-96
pubmed: 26095389
Gastric Cancer. 2017 May;20(3):508-516
pubmed: 27568321
Asian J Endosc Surg. 2020 Jan;13(1):7-18
pubmed: 31828925
Lancet Gastroenterol Hepatol. 2017 Apr;2(4):261-268
pubmed: 28404155
Clin Trials. 2006;3(1):10-8
pubmed: 16539086
Br J Surg. 2010 Nov;97(11):1638-45
pubmed: 20629110
Ann Surg. 2014 Jul;260(1):23-30
pubmed: 24509190
N Engl J Med. 2004 May 13;350(20):2050-9
pubmed: 15141043
Surg Endosc. 2005 May;19(5):687-92
pubmed: 15798899
Surgery. 2009 Jun;145(6):598-602
pubmed: 19486758
Eur J Surg Oncol. 2020 Sep;46(9):1642-1648
pubmed: 32340817