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)

Int J Colorectal Dis. 2017 Sep;32(9):1357-1362. doi: 10.1007/s00384-017-2842-4. Epub 2017 Jun 30.

Abstract

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.

Keywords: Coloanal anastomosis; Pull-through; Sphincter-sparing rectal resection; Turnbull-Cutait technique; Ultra-low rectal cancer.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adenocarcinoma / pathology
  • Adenocarcinoma / physiopathology
  • Adenocarcinoma / surgery*
  • Adult
  • Aged
  • Anal Canal / pathology
  • Anal Canal / physiopathology
  • Anal Canal / surgery*
  • Anastomosis, Surgical
  • Clinical Protocols
  • Colon / pathology
  • Colon / physiopathology
  • Colon / surgery*
  • Defecation
  • Digestive System Surgical Procedures / adverse effects
  • Digestive System Surgical Procedures / methods*
  • Female
  • Gastrointestinal Motility
  • Humans
  • Ileostomy* / adverse effects
  • Italy
  • Male
  • Middle Aged
  • Neoplasm Recurrence, Local
  • Postoperative Complications / etiology
  • Quality of Life
  • Recovery of Function
  • Rectal Neoplasms / pathology
  • Rectal Neoplasms / physiopathology
  • Rectal Neoplasms / surgery*
  • Research Design
  • Risk Factors
  • Spain
  • Time Factors
  • Treatment Outcome
  • Young Adult

Associated data

  • ClinicalTrials.gov/NCT01766661