Multicentre randomized clinical trial of colonic J pouch or straight stapled colorectal reconstruction after low anterior resection for rectal cancer

S. Pucciarelli, P. Del Bianco, U. Pace, F. Bianco, A. Restivo, I. Maretto, F. Selvaggi, L. Zorcolo, S. De Franciscis, C. Asteria, E. D.L. Urso, D. Cuicchi, G. Pellino, E. Morpurgo, G. La Torre, E. Jovine, C. Belluco, F. La Torre, A. Amato, A. ChiappaA. Infantino, A. Barina, G. Spolverato, D. Rega, D. Kilmartin, G. L. De Salvo, P. Delrio

Research output: Contribution to journalArticle

Abstract

Background: Colonic J pouch reconstruction has been found to be associated with a lower incidence of anastomotic leakage than straight anastomosis. However, studies on this topic are underpowered and retrospective. This randomized trial evaluated whether the incidence of anastomotic leakage was reduced after colonic J pouch reconstruction compared with straight colorectal anastomosis following anterior resection for rectal cancer. Methods: This multicentre RCT included patients with rectal carcinoma who underwent low anterior resection followed by colorectal anastomosis. Patients were assigned randomly to receive a colonic J pouch or straight colorectal anastomosis. The main outcome measure was the occurrence of major anastomotic leakage. The incidence of global (major plus minor) anastomotic leakage and general complications were secondary outcomes. Risk factors for anastomotic leakage were identified by regression analysis. Results: Of 457 patients enrolled, 379 were evaluable (colonic J pouch arm 190, straight colorectal arm 189). The incidence of major and global anastomotic leakage, and general complications was 14·2, 19·5 and 34·2 per cent respectively in the colonic J pouch group, and 12·2, 19·0 and 27·0 per cent in the straight colorectal anastomosis group. No statistically significant differences were observed between the two arms. In multivariable logistic regression analysis, male sex (odds ratio 1·79, 95 per cent c.i. 1·02 to 3·15; P = 0·042) and high ASA fitness grade (odds ratio 2·06, 1·15 to 3·71; P = 0·015) were independently associated with the occurrence of anastomotic leakage. Conclusion: Colonic J pouch reconstruction does not reduce the incidence of anastomotic leakage and postoperative complications compared with conventional straight colorectal anastomosis. Registration number NCT01110798 (http://www.clinicaltrials.gov).

Original languageEnglish
JournalBritish Journal of Surgery
DOIs
Publication statusPublished - Jan 1 2019

Fingerprint

Colonic Pouches
Rectal Neoplasms
Anastomotic Leak
Randomized Controlled Trials
Incidence
Odds Ratio
Regression Analysis
Sex Ratio

ASJC Scopus subject areas

  • Surgery

Cite this

Multicentre randomized clinical trial of colonic J pouch or straight stapled colorectal reconstruction after low anterior resection for rectal cancer. / Pucciarelli, S.; Del Bianco, P.; Pace, U.; Bianco, F.; Restivo, A.; Maretto, I.; Selvaggi, F.; Zorcolo, L.; De Franciscis, S.; Asteria, C.; Urso, E. D.L.; Cuicchi, D.; Pellino, G.; Morpurgo, E.; La Torre, G.; Jovine, E.; Belluco, C.; La Torre, F.; Amato, A.; Chiappa, A.; Infantino, A.; Barina, A.; Spolverato, G.; Rega, D.; Kilmartin, D.; De Salvo, G. L.; Delrio, P.

In: British Journal of Surgery, 01.01.2019.

Research output: Contribution to journalArticle

Pucciarelli, S, Del Bianco, P, Pace, U, Bianco, F, Restivo, A, Maretto, I, Selvaggi, F, Zorcolo, L, De Franciscis, S, Asteria, C, Urso, EDL, Cuicchi, D, Pellino, G, Morpurgo, E, La Torre, G, Jovine, E, Belluco, C, La Torre, F, Amato, A, Chiappa, A, Infantino, A, Barina, A, Spolverato, G, Rega, D, Kilmartin, D, De Salvo, GL & Delrio, P 2019, 'Multicentre randomized clinical trial of colonic J pouch or straight stapled colorectal reconstruction after low anterior resection for rectal cancer', British Journal of Surgery. https://doi.org/10.1002/bjs.11222
Pucciarelli, S. ; Del Bianco, P. ; Pace, U. ; Bianco, F. ; Restivo, A. ; Maretto, I. ; Selvaggi, F. ; Zorcolo, L. ; De Franciscis, S. ; Asteria, C. ; Urso, E. D.L. ; Cuicchi, D. ; Pellino, G. ; Morpurgo, E. ; La Torre, G. ; Jovine, E. ; Belluco, C. ; La Torre, F. ; Amato, A. ; Chiappa, A. ; Infantino, A. ; Barina, A. ; Spolverato, G. ; Rega, D. ; Kilmartin, D. ; De Salvo, G. L. ; Delrio, P. / Multicentre randomized clinical trial of colonic J pouch or straight stapled colorectal reconstruction after low anterior resection for rectal cancer. In: British Journal of Surgery. 2019.
@article{cc177b08cd8449db98fe17bd7c33bbf5,
title = "Multicentre randomized clinical trial of colonic J pouch or straight stapled colorectal reconstruction after low anterior resection for rectal cancer",
abstract = "Background: Colonic J pouch reconstruction has been found to be associated with a lower incidence of anastomotic leakage than straight anastomosis. However, studies on this topic are underpowered and retrospective. This randomized trial evaluated whether the incidence of anastomotic leakage was reduced after colonic J pouch reconstruction compared with straight colorectal anastomosis following anterior resection for rectal cancer. Methods: This multicentre RCT included patients with rectal carcinoma who underwent low anterior resection followed by colorectal anastomosis. Patients were assigned randomly to receive a colonic J pouch or straight colorectal anastomosis. The main outcome measure was the occurrence of major anastomotic leakage. The incidence of global (major plus minor) anastomotic leakage and general complications were secondary outcomes. Risk factors for anastomotic leakage were identified by regression analysis. Results: Of 457 patients enrolled, 379 were evaluable (colonic J pouch arm 190, straight colorectal arm 189). The incidence of major and global anastomotic leakage, and general complications was 14·2, 19·5 and 34·2 per cent respectively in the colonic J pouch group, and 12·2, 19·0 and 27·0 per cent in the straight colorectal anastomosis group. No statistically significant differences were observed between the two arms. In multivariable logistic regression analysis, male sex (odds ratio 1·79, 95 per cent c.i. 1·02 to 3·15; P = 0·042) and high ASA fitness grade (odds ratio 2·06, 1·15 to 3·71; P = 0·015) were independently associated with the occurrence of anastomotic leakage. Conclusion: Colonic J pouch reconstruction does not reduce the incidence of anastomotic leakage and postoperative complications compared with conventional straight colorectal anastomosis. Registration number NCT01110798 (http://www.clinicaltrials.gov).",
author = "S. Pucciarelli and {Del Bianco}, P. and U. Pace and F. Bianco and A. Restivo and I. Maretto and F. Selvaggi and L. Zorcolo and {De Franciscis}, S. and C. Asteria and Urso, {E. D.L.} and D. Cuicchi and G. Pellino and E. Morpurgo and {La Torre}, G. and E. Jovine and C. Belluco and {La Torre}, F. and A. Amato and A. Chiappa and A. Infantino and A. Barina and G. Spolverato and D. Rega and D. Kilmartin and {De Salvo}, {G. L.} and P. Delrio",
year = "2019",
month = "1",
day = "1",
doi = "10.1002/bjs.11222",
language = "English",
journal = "British Journal of Surgery",
issn = "0007-1323",
publisher = "John Wiley and Sons Ltd",

}

TY - JOUR

T1 - Multicentre randomized clinical trial of colonic J pouch or straight stapled colorectal reconstruction after low anterior resection for rectal cancer

AU - Pucciarelli, S.

AU - Del Bianco, P.

AU - Pace, U.

AU - Bianco, F.

AU - Restivo, A.

AU - Maretto, I.

AU - Selvaggi, F.

AU - Zorcolo, L.

AU - De Franciscis, S.

AU - Asteria, C.

AU - Urso, E. D.L.

AU - Cuicchi, D.

AU - Pellino, G.

AU - Morpurgo, E.

AU - La Torre, G.

AU - Jovine, E.

AU - Belluco, C.

AU - La Torre, F.

AU - Amato, A.

AU - Chiappa, A.

AU - Infantino, A.

AU - Barina, A.

AU - Spolverato, G.

AU - Rega, D.

AU - Kilmartin, D.

AU - De Salvo, G. L.

AU - Delrio, P.

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background: Colonic J pouch reconstruction has been found to be associated with a lower incidence of anastomotic leakage than straight anastomosis. However, studies on this topic are underpowered and retrospective. This randomized trial evaluated whether the incidence of anastomotic leakage was reduced after colonic J pouch reconstruction compared with straight colorectal anastomosis following anterior resection for rectal cancer. Methods: This multicentre RCT included patients with rectal carcinoma who underwent low anterior resection followed by colorectal anastomosis. Patients were assigned randomly to receive a colonic J pouch or straight colorectal anastomosis. The main outcome measure was the occurrence of major anastomotic leakage. The incidence of global (major plus minor) anastomotic leakage and general complications were secondary outcomes. Risk factors for anastomotic leakage were identified by regression analysis. Results: Of 457 patients enrolled, 379 were evaluable (colonic J pouch arm 190, straight colorectal arm 189). The incidence of major and global anastomotic leakage, and general complications was 14·2, 19·5 and 34·2 per cent respectively in the colonic J pouch group, and 12·2, 19·0 and 27·0 per cent in the straight colorectal anastomosis group. No statistically significant differences were observed between the two arms. In multivariable logistic regression analysis, male sex (odds ratio 1·79, 95 per cent c.i. 1·02 to 3·15; P = 0·042) and high ASA fitness grade (odds ratio 2·06, 1·15 to 3·71; P = 0·015) were independently associated with the occurrence of anastomotic leakage. Conclusion: Colonic J pouch reconstruction does not reduce the incidence of anastomotic leakage and postoperative complications compared with conventional straight colorectal anastomosis. Registration number NCT01110798 (http://www.clinicaltrials.gov).

AB - Background: Colonic J pouch reconstruction has been found to be associated with a lower incidence of anastomotic leakage than straight anastomosis. However, studies on this topic are underpowered and retrospective. This randomized trial evaluated whether the incidence of anastomotic leakage was reduced after colonic J pouch reconstruction compared with straight colorectal anastomosis following anterior resection for rectal cancer. Methods: This multicentre RCT included patients with rectal carcinoma who underwent low anterior resection followed by colorectal anastomosis. Patients were assigned randomly to receive a colonic J pouch or straight colorectal anastomosis. The main outcome measure was the occurrence of major anastomotic leakage. The incidence of global (major plus minor) anastomotic leakage and general complications were secondary outcomes. Risk factors for anastomotic leakage were identified by regression analysis. Results: Of 457 patients enrolled, 379 were evaluable (colonic J pouch arm 190, straight colorectal arm 189). The incidence of major and global anastomotic leakage, and general complications was 14·2, 19·5 and 34·2 per cent respectively in the colonic J pouch group, and 12·2, 19·0 and 27·0 per cent in the straight colorectal anastomosis group. No statistically significant differences were observed between the two arms. In multivariable logistic regression analysis, male sex (odds ratio 1·79, 95 per cent c.i. 1·02 to 3·15; P = 0·042) and high ASA fitness grade (odds ratio 2·06, 1·15 to 3·71; P = 0·015) were independently associated with the occurrence of anastomotic leakage. Conclusion: Colonic J pouch reconstruction does not reduce the incidence of anastomotic leakage and postoperative complications compared with conventional straight colorectal anastomosis. Registration number NCT01110798 (http://www.clinicaltrials.gov).

UR - http://www.scopus.com/inward/record.url?scp=85068154283&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85068154283&partnerID=8YFLogxK

U2 - 10.1002/bjs.11222

DO - 10.1002/bjs.11222

M3 - Article

AN - SCOPUS:85068154283

JO - British Journal of Surgery

JF - British Journal of Surgery

SN - 0007-1323

ER -