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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)
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)...
Autores principales: | , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8560602/ https://www.ncbi.nlm.nih.gov/pubmed/34755014 http://dx.doi.org/10.1002/ags3.12484 |
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author | Katayama, Hiroshi Inomata, Masafumi Mizusawa, Junki Nakamura, Kenichi Watanabe, Masahiko Akagi, Tomonori Yamamoto, Seiichiro Ito, Masaaki Kinugasa, Yusuke Okajima, Masazumi Takemasa, Ichiro Okuda, Junji Shida, Dai Kanemitsu, Yukihide Kitano, Seigo |
author_facet | Katayama, Hiroshi Inomata, Masafumi Mizusawa, Junki Nakamura, Kenichi Watanabe, Masahiko Akagi, Tomonori Yamamoto, Seiichiro Ito, Masaaki Kinugasa, Yusuke Okajima, Masazumi Takemasa, Ichiro Okuda, Junji Shida, Dai Kanemitsu, Yukihide Kitano, Seigo |
author_sort | Katayama, Hiroshi |
collection | PubMed |
description | 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: 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: 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: 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. |
format | Online Article Text |
id | pubmed-8560602 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-85606022021-11-08 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) Katayama, Hiroshi Inomata, Masafumi Mizusawa, Junki Nakamura, Kenichi Watanabe, Masahiko Akagi, Tomonori Yamamoto, Seiichiro Ito, Masaaki Kinugasa, Yusuke Okajima, Masazumi Takemasa, Ichiro Okuda, Junji Shida, Dai Kanemitsu, Yukihide Kitano, Seigo Ann Gastroenterol Surg Original Articles 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: 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: 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: 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. John Wiley and Sons Inc. 2021-07-12 /pmc/articles/PMC8560602/ /pubmed/34755014 http://dx.doi.org/10.1002/ags3.12484 Text en © 2021 The Authors. Annals of Gastroenterological Surgery published by John Wiley & Sons Australia, Ltd on behalf of The Japanese Society of Gastroenterology https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Original Articles Katayama, Hiroshi Inomata, Masafumi Mizusawa, Junki Nakamura, Kenichi Watanabe, Masahiko Akagi, Tomonori Yamamoto, Seiichiro Ito, Masaaki Kinugasa, Yusuke Okajima, Masazumi Takemasa, Ichiro Okuda, Junji Shida, Dai Kanemitsu, Yukihide Kitano, Seigo 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) |
title | 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) |
title_full | 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) |
title_fullStr | 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) |
title_full_unstemmed | 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) |
title_short | 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) |
title_sort | 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) |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8560602/ https://www.ncbi.nlm.nih.gov/pubmed/34755014 http://dx.doi.org/10.1002/ags3.12484 |
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