S Pucciarelli1, P Del Bianco2, U Pace3, F Bianco4, A Restivo5, I Maretto1, F Selvaggi6, L Zorcolo5, S De Franciscis4, C Asteria7, E D L Urso1, D Cuicchi8, G Pellino6, E Morpurgo9, G La Torre10, E Jovine11, C Belluco12, F La Torre13, A Amato14, A Chiappa15, A Infantino16, A Barina1, G Spolverato1, D Rega3, D Kilmartin2, G L De Salvo2, P Delrio3. 1. First Surgical Clinic, Department of Surgical, Oncological and Gastroenterological Sciences, University of Padua, Padua, Italy. 2. Clinical Trials and Biostatistics Unit, Istituto Oncologico Veneto IOV - IRCCS, Padua, Italy. 3. Department of Colorectal Surgical Oncology, Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale, Naples, Italy. 4. Department of Abdominal Oncology, Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale, Naples, Italy. 5. Colorectal Surgery, Azienda Ospedaliero-Universitaria di Cagliari, Department of Surgical Science, University of Cagliari, Cagliari, Italy. 6. Colorectal Surgery Unit, Department of Medical, Surgical, Neurological, Metabolic and Ageing Sciences, University of Campania 'Luigi Vanvitelli', Naples, Italy. 7. Department of General Surgery, Ospedale Carlo Poma, Mantua, Italy. 8. General Surgery Unit, Department of Alimentary Tract, Sant'Orsola-Malpighi Hospital, Bologna, Italy. 9. Department of Surgery, Regional Centre for Laparoscopic and Robotic Surgery, Camposampiero Hospital, Padua, Italy. 10. Abdominal Surgical Oncology, Department of Surgery, IRCCS, Centro di Riferimento oncologico della Basilicata, Rionero in Vulture, Italy. 11. General Surgery and Emergency, Maggiore Hospital, Azienda Sanitaria Locale di Bologna, Bologna, Italy. 12. Department of Surgical Oncology, Centro di Riferimento Oncologico -IRCCS, National Cancer Institute, Aviano, Italy. 13. Division of Emergency and Trauma Surgery, Emergency Department, Policlinico Umberto I, College of Medicine and Dentistry, Sapienza University, Rome, Italy. 14. Department of Coloproctology, Sanremo Hospital, Sanremo, Italy. 15. Innovative Techniques in Surgery Unit, European Institute of Oncology, University of Milan, Milan, Italy. 16. Surgical Unit, Department of General Surgery, Santa Maria dei Battuti Hospital, San Vito al Tagliamento, Italy.
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).
RCT Entities:
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).
Authors: V Pla-Martí; J Martín-Arévalo; D Moro-Valdezate; S García-Botello; I Mora-Oliver; R Gadea-Mateo; C Cozar-Lozano; A Espí-Macías Journal: Tech Coloproctol Date: 2020-09-10 Impact factor: 3.781
Authors: Francesco Bianco; Paola Incollingo; Armando Falato; Silvia De Franciscis; Andrea Belli; Fabio Carbone; Gaetano Gallo; Mario Fusco; Giovanni Maria Romano Journal: Updates Surg Date: 2021-03-16
Authors: Pim Edomskis; Max R Goudberg; Cloë L Sparreboom; Anand G Menon; Albert M Wolthuis; Andre D'Hoore; Johan F Lange Journal: Int J Colorectal Dis Date: 2020-08-31 Impact factor: 2.571