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Transitional impact of short‐ and long‐term outcomes of a randomized controlled trial to evaluate laparoscopic versus open surgery for colorectal cancer from Japan Clinical Oncology Group Study JCOG0404

BACKGROUND: The JCOG0404 randomized controlled trial conducted to compare laparoscopic surgery (LAP) with open surgery (OP) for stage II/III colon cancer showed better short‐term outcomes and equal long‐term outcomes of LAP versus OP. Technical instrumentation of surgery and anticancer agents given...

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Autores principales: Fujii, Shoichi, Akagi, Tomonori, Inomata, Masafumi, Katayama, Hiroshi, Mizusawa, Junki, Ota, Mitsuyoshi, Saito, Shuji, Kinugasa, Yusuke, Yamaguchi, Shigeki, Sato, Takeo, Kitano, Seigo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6524094/
https://www.ncbi.nlm.nih.gov/pubmed/31131359
http://dx.doi.org/10.1002/ags3.12245
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author Fujii, Shoichi
Akagi, Tomonori
Inomata, Masafumi
Katayama, Hiroshi
Mizusawa, Junki
Ota, Mitsuyoshi
Saito, Shuji
Kinugasa, Yusuke
Yamaguchi, Shigeki
Sato, Takeo
Kitano, Seigo
author_facet Fujii, Shoichi
Akagi, Tomonori
Inomata, Masafumi
Katayama, Hiroshi
Mizusawa, Junki
Ota, Mitsuyoshi
Saito, Shuji
Kinugasa, Yusuke
Yamaguchi, Shigeki
Sato, Takeo
Kitano, Seigo
author_sort Fujii, Shoichi
collection PubMed
description BACKGROUND: The JCOG0404 randomized controlled trial conducted to compare laparoscopic surgery (LAP) with open surgery (OP) for stage II/III colon cancer showed better short‐term outcomes and equal long‐term outcomes of LAP versus OP. Technical instrumentation of surgery and anticancer agents given during the registration period might have affected the outcomes. AIM: To evaluate outcomes according to the registration periods. METHODS: The overall registration period was divided into three periods (first: 2004‐2005, second: 2006‐2007 and third: 2008‐2009). Short‐term and long‐term outcomes were compared between registration periods. RESULTS: In total, 1057 patients were registered. Numbers of patients undergoing each approach for each of the three periods (1st/2nd/3rd) were 528 for OP (106/244/178) and 529 for LAP (106/246/177). Operation time (minutes) did not change between the periods for OP (160/156/161) or LAP (205/211/219). Blood loss (mL) gradually decreased in the latter two periods: (119/80/75) for OP and (35/28/25) for LAP. Incidence of complications (%) decreased in the latter periods for OP (27.6/20.3/21.3), whereas that for LAP remained consistently low (14.3/14.8/13.6). There was no particular trend in 5‐year overall survival and recurrence‐free survival depending on the period regardless of treatment. D3 dissection rates were 95% or more for all periods in both groups. CONCLUSIONS: Operation time and survival rates did not change over time, whereas blood loss in OP improved in the latter periods. Quality control applied in this trial might have been effective in producing such safe endpoints. (ClinicalTrials.gov, number NCT00147134, UMIN Clinical Trials Registry, number C000000105.)
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spelling pubmed-65240942019-05-24 Transitional impact of short‐ and long‐term outcomes of a randomized controlled trial to evaluate laparoscopic versus open surgery for colorectal cancer from Japan Clinical Oncology Group Study JCOG0404 Fujii, Shoichi Akagi, Tomonori Inomata, Masafumi Katayama, Hiroshi Mizusawa, Junki Ota, Mitsuyoshi Saito, Shuji Kinugasa, Yusuke Yamaguchi, Shigeki Sato, Takeo Kitano, Seigo Ann Gastroenterol Surg Original Articles BACKGROUND: The JCOG0404 randomized controlled trial conducted to compare laparoscopic surgery (LAP) with open surgery (OP) for stage II/III colon cancer showed better short‐term outcomes and equal long‐term outcomes of LAP versus OP. Technical instrumentation of surgery and anticancer agents given during the registration period might have affected the outcomes. AIM: To evaluate outcomes according to the registration periods. METHODS: The overall registration period was divided into three periods (first: 2004‐2005, second: 2006‐2007 and third: 2008‐2009). Short‐term and long‐term outcomes were compared between registration periods. RESULTS: In total, 1057 patients were registered. Numbers of patients undergoing each approach for each of the three periods (1st/2nd/3rd) were 528 for OP (106/244/178) and 529 for LAP (106/246/177). Operation time (minutes) did not change between the periods for OP (160/156/161) or LAP (205/211/219). Blood loss (mL) gradually decreased in the latter two periods: (119/80/75) for OP and (35/28/25) for LAP. Incidence of complications (%) decreased in the latter periods for OP (27.6/20.3/21.3), whereas that for LAP remained consistently low (14.3/14.8/13.6). There was no particular trend in 5‐year overall survival and recurrence‐free survival depending on the period regardless of treatment. D3 dissection rates were 95% or more for all periods in both groups. CONCLUSIONS: Operation time and survival rates did not change over time, whereas blood loss in OP improved in the latter periods. Quality control applied in this trial might have been effective in producing such safe endpoints. (ClinicalTrials.gov, number NCT00147134, UMIN Clinical Trials Registry, number C000000105.) John Wiley and Sons Inc. 2019-03-26 /pmc/articles/PMC6524094/ /pubmed/31131359 http://dx.doi.org/10.1002/ags3.12245 Text en © 2019 The Authors. Annals of Gastroenterological Surgery published by John Wiley & Sons Australia, Ltd on behalf of The Japanese Society of Gastroenterological Surgery This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Articles
Fujii, Shoichi
Akagi, Tomonori
Inomata, Masafumi
Katayama, Hiroshi
Mizusawa, Junki
Ota, Mitsuyoshi
Saito, Shuji
Kinugasa, Yusuke
Yamaguchi, Shigeki
Sato, Takeo
Kitano, Seigo
Transitional impact of short‐ and long‐term outcomes of a randomized controlled trial to evaluate laparoscopic versus open surgery for colorectal cancer from Japan Clinical Oncology Group Study JCOG0404
title Transitional impact of short‐ and long‐term outcomes of a randomized controlled trial to evaluate laparoscopic versus open surgery for colorectal cancer from Japan Clinical Oncology Group Study JCOG0404
title_full Transitional impact of short‐ and long‐term outcomes of a randomized controlled trial to evaluate laparoscopic versus open surgery for colorectal cancer from Japan Clinical Oncology Group Study JCOG0404
title_fullStr Transitional impact of short‐ and long‐term outcomes of a randomized controlled trial to evaluate laparoscopic versus open surgery for colorectal cancer from Japan Clinical Oncology Group Study JCOG0404
title_full_unstemmed Transitional impact of short‐ and long‐term outcomes of a randomized controlled trial to evaluate laparoscopic versus open surgery for colorectal cancer from Japan Clinical Oncology Group Study JCOG0404
title_short Transitional impact of short‐ and long‐term outcomes of a randomized controlled trial to evaluate laparoscopic versus open surgery for colorectal cancer from Japan Clinical Oncology Group Study JCOG0404
title_sort transitional impact of short‐ and long‐term outcomes of a randomized controlled trial to evaluate laparoscopic versus open surgery for colorectal cancer from japan clinical oncology group study jcog0404
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6524094/
https://www.ncbi.nlm.nih.gov/pubmed/31131359
http://dx.doi.org/10.1002/ags3.12245
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