학술논문
Two-stage Turnbull-Cutait pull-through coloanal anastomosis versus coloanal anastomosis with protective loop ileostomy for low rectal cancer. Protocol for a randomized controlled trial (Turnbull-BCN)
Clinical Study Protocol
Clinical Study Protocol
Document Type
Clinical report
Author
Source
International Journal of Colorectal Disease. September 2017, Vol. 32 Issue 9, p1357, 6 p.
Subject
Language
English
ISSN
0179-1958
Abstract
Author(s): Sebastiano Biondo [sup.1], Loris Trenti [sup.1], Ana Galvez [sup.1], Eloy Espin-Basany [sup.2], Francesco Bianco [sup.3], Giovanni Romano [sup.3], Esther Kreisler [sup.1], Ana Blanco-Alvarez, Cristina Quiñones-Sanchez, Jose Jerez-Gonzalez, Thomas Golda, [...]
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.
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.