Sebastiano Biondo1, Loris Trenti2, Ana Galvez2, Eloy Espin-Basany3, Francesco Bianco4, Giovanni Romano4, Esther Kreisler2. 1. Department of General and Digestive Surgery, Colorectal Unit, Bellvitge University Hospital, University of Barcelona and IDIBELL, C/ Feixa Llarga s/n, L'Hospitalet de Llobregat, 08907, Barcelona, Spain. sbn.biondo@gmail.com. 2. Department of General and Digestive Surgery, Colorectal Unit, Bellvitge University Hospital, University of Barcelona and IDIBELL, C/ Feixa Llarga s/n, L'Hospitalet de Llobregat, 08907, Barcelona, Spain. 3. Department of General and Digestive Surgery, Colorectal Unit, Vall d'Hebron University Hospital, Autonomic University of Barcelona, Barcelona, Spain. 4. Department of Abdominal Oncologic Surgery, National Cancer Institute "G. Pascale", Naples, Italy.
Abstract
PURPOSE: The aim of this study was to determine whether patients that underwentultra-low rectal resection for cancer can benefit from the recently reintroduced two-stage Turnbull-Cutait abdominoperineal pull-through procedure. METHODS:Patients with low rectal tumors undergoingradical sphincter-sparing resection are eligible for inclusion in a randomized multicenter study. Whether two-stage Turnbull-Cutait coloanal anastomosis provides significant benefits over hand-sewn coloanal anastomosis and associated lateral ileostomy in terms of postoperative morbidity is the primary endpoint. In addition, the study aims to assess secondary endpoints such as quality of life, fecal incontinence, and locoregional recurrence of the neoplasm. Patients with adenocarcinoma of the lower rectum diagnosed by rigid proctoscopy, with histological confirmation of malignancy, and who are candidates of rectal removal and coloanal anastomosis will be included in a randomized controlled and multicenter trial. Postoperative morbidity is defined as complications that occur within 30 days of the data of the second surgical procedure of the last patient included in the trial. Patients will be followed for a minimum period of 3 years. CONCLUSIONS: The two-stage Turnbull-Cutait coloanal anastomosis may constitute an effective surgical alternative in the current approach to the treatment of low rectal cancer without the need of a temporary loop colostomy, preventing the wide range of complications related to stoma surgery. TRIAL REGISTRATION: This trial is registered at clinicaltrials.gov (trial number: NCT01766661). This trial is registered in January 10, 2013.
RCT Entities:
PURPOSE: The aim of this study was to determine whether patients that underwent ultra-low rectal resection for cancer can benefit from the recently reintroduced two-stage Turnbull-Cutait abdominoperineal pull-through procedure. METHODS:Patients with low rectal tumors undergoing radical sphincter-sparing resection are eligible for inclusion in a randomized multicenter study. Whether two-stage Turnbull-Cutait coloanal anastomosis provides significant benefits over hand-sewn coloanal anastomosis and associated lateral ileostomy in terms of postoperative morbidity is the primary endpoint. In addition, the study aims to assess secondary endpoints such as quality of life, fecal incontinence, and locoregional recurrence of the neoplasm. Patients with adenocarcinoma of the lower rectum diagnosed by rigid proctoscopy, with histological confirmation of malignancy, and who are candidates of rectal removal and coloanal anastomosis will be included in a randomized controlled and multicenter trial. Postoperative morbidity is defined as complications that occur within 30 days of the data of the second surgical procedure of the last patient included in the trial. Patients will be followed for a minimum period of 3 years. CONCLUSIONS: The two-stage Turnbull-Cutait coloanal anastomosis may constitute an effective surgical alternative in the current approach to the treatment of low rectal cancer without the need of a temporary loop colostomy, preventing the wide range of complications related to stoma surgery. TRIAL REGISTRATION: This trial is registered at clinicaltrials.gov (trial number: NCT01766661). This trial is registered in January 10, 2013.
Authors: Anne K Danielsen; Jennifer Park; Jens E Jansen; David Bock; Stefan Skullman; Anette Wedin; Adiela Correa Marinez; Eva Haglind; Eva Angenete; Jacob Rosenberg Journal: Ann Surg Date: 2017-02 Impact factor: 12.969
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