Study protocol: a multicenter randomized controlled trial to evaluate the length of hospital stay of intracorporeal versus extracorporeal anastomosis in laparoscopic colectomy for colon cancer (CONNECT study).
Colon cancer
Extracorporeal anastomosis
Intracorporeal anastomosis
Laparoscopic colectomy
Side-to-side anastomosis
Journal
International journal of colorectal disease
ISSN: 1432-1262
Titre abrégé: Int J Colorectal Dis
Pays: Germany
ID NLM: 8607899
Informations de publication
Date de publication:
Jun 2021
Jun 2021
Historique:
accepted:
27
01
2021
pubmed:
3
2
2021
medline:
24
6
2021
entrez:
2
2
2021
Statut:
ppublish
Résumé
Randomized controlled trials (RCTs) comparing intracorporeal anastomosis (IA) and extracorporeal anastomosis (EA) could not prove a significant reduction in postoperative stay and therefore did not provide sufficient evidence of IA. Recently, we reported a new intracorporeal anastomosis method and intracorporeal end-to-end anastomosis (IEEA). However, there have been no studies comparing intracorporeal side-to-side anastomosis (ISSA) to IEEA. The main purpose of this study is to verify the superiority of IA over EA. The secondary purpose is to compare IEEA with ISSA. Patients scheduled to undergo laparoscopic colectomy for colon cancer are recruited to the CONNECT study (multicenter, single-blind, randomized controlled study), cases in which anastomosis by the double-stapling technique is planned will be excluded. The target sample size is set at 300 cases in total, which will be randomized into 3 groups (EA, IEEA, and ISSA) in a 2:1:1 ratio. The primary endpoint is the length of postoperative hospital stay in the IA and EA groups; the secondly endpoint is the anastomotic time in IEEA and ISSA groups. We will also evaluate SF-36 ver.2, EORTC QLQ-C30 ver.3, operator stress using SURG-TLX, and the long-term outcomes, such as 5-year disease-free survival and overall survival. This RCT will compare the postoperative length of stay between IA and EA in twice the number of cases of previous RCTs. Concurrently, although as a secondary purpose, this will be the first study to compare IEEA and ISSA. This trial was registered with the UMIN Clinical Trials Registry in September 2020 as UMIN000041565.
Sections du résumé
BACKGROUND
BACKGROUND
Randomized controlled trials (RCTs) comparing intracorporeal anastomosis (IA) and extracorporeal anastomosis (EA) could not prove a significant reduction in postoperative stay and therefore did not provide sufficient evidence of IA. Recently, we reported a new intracorporeal anastomosis method and intracorporeal end-to-end anastomosis (IEEA). However, there have been no studies comparing intracorporeal side-to-side anastomosis (ISSA) to IEEA.
PURPOSE
OBJECTIVE
The main purpose of this study is to verify the superiority of IA over EA. The secondary purpose is to compare IEEA with ISSA.
METHODS
METHODS
Patients scheduled to undergo laparoscopic colectomy for colon cancer are recruited to the CONNECT study (multicenter, single-blind, randomized controlled study), cases in which anastomosis by the double-stapling technique is planned will be excluded. The target sample size is set at 300 cases in total, which will be randomized into 3 groups (EA, IEEA, and ISSA) in a 2:1:1 ratio. The primary endpoint is the length of postoperative hospital stay in the IA and EA groups; the secondly endpoint is the anastomotic time in IEEA and ISSA groups. We will also evaluate SF-36 ver.2, EORTC QLQ-C30 ver.3, operator stress using SURG-TLX, and the long-term outcomes, such as 5-year disease-free survival and overall survival.
CONCLUSIONS
CONCLUSIONS
This RCT will compare the postoperative length of stay between IA and EA in twice the number of cases of previous RCTs. Concurrently, although as a secondary purpose, this will be the first study to compare IEEA and ISSA.
TRIAL REGISTRATION
BACKGROUND
This trial was registered with the UMIN Clinical Trials Registry in September 2020 as UMIN000041565.
Identifiants
pubmed: 33528751
doi: 10.1007/s00384-021-03869-y
pii: 10.1007/s00384-021-03869-y
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1323-1328Références
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