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.
colorectal cancer
laparoscopic colectomy
randomized controlled trial
transitional impact
Journal
Annals of gastroenterological surgery
ISSN: 2475-0328
Titre abrégé: Ann Gastroenterol Surg
Pays: Japan
ID NLM: 101718062
Informations de publication
Date de publication:
May 2019
May 2019
Historique:
received:
19
12
2018
revised:
04
02
2019
accepted:
17
02
2019
entrez:
28
5
2019
pubmed:
28
5
2019
medline:
28
5
2019
Statut:
epublish
Résumé
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. To evaluate outcomes according to the registration periods. 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. 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. 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.).
Sections du résumé
BACKGROUND
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
OBJECTIVE
To evaluate outcomes according to the registration periods.
METHODS
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
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
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.).
Identifiants
pubmed: 31131359
doi: 10.1002/ags3.12245
pii: AGS312245
pmc: PMC6524094
doi:
Banques de données
ClinicalTrials.gov
['NCT00147134']
Types de publication
Journal Article
Langues
eng
Pagination
301-309Références
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