Prospective Multicenter Randomized Controlled Trial On Two-Stage Turnbull-Cutait Coloanal Anastomosis For Rectal

Not Applicable

• Conditions: Rectal Neoplasm
• Interventions: Procedure: Hand-sewn coloanal anastomosis; Procedure: Two staged Turnbull-Cutait procedure; Procedure: Ultralow anterior rectal resection with total mesorectal excision

• Registration Number: NCT01766661
• Lead Sponsor: Hospital Universitari de Bellvitge

Brief Summary

The aim of this study is to decrease the morbidity by 30% using the Turnbull-Cutait procedure in comparison to the standard surgery for low rectal cancer. The investigators compare quality of life, faecal incontinence and recurrence of neoplasm in patients who received standard colo-anal anastomosis with protective ileostomy or two-staged Turnbull-Cutait colo-anal anastomosis after Low Anterior Resection for rectal cancer.

Detailed Description

Anastomotic leak represents the most frequent complication after rectal cancer surgery and a lateral covering ileostomy is usually performed to reduce its incidence. Other important consequences of rectal cancer surgery are alterations in bowel habits and function and a negative impact on quality of life. This prospective, randomized, multicenter and controlled trial compares post-operative complications, quality of life, faecal incontinence and recurrence rate in patients treated for low rectal cancer with colo-anal anastomosis protected by a lateral ileostomy or with a two-staged Turnbull-Cutait colo-anal anastomosis.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-10
• Study First Submitted QC: 2013-01-10
• Study First Posted: 2013-01-11
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-27
• Primary Completion: 2019-03
• Study Completion: 2022-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• Patients with adenocarcinoma of the lower-middle third of the rectum proctoscopy established by rigid proctoscopy, with histological confirmation and candidates of colo-anal anastomosis;
• Patients over 18 years and under 75 years, who can tolerate neoadjuvant and surgical treatment;
• Patients who undergo an ultra-low anterior rectal resection with total mesorectal excision and nerve and sphincter-sparing with curative intention
• Any extension of the primary tumor (T 1-2-3-4) according to the TNM classification;
• Patients with or without lymph node metastasis (N - / +) and with or without resectable distant metastases;
• Patients clinically without fecal incontinence prior to the current illness and with a Wexner incontinence Score less than or equal to 5;
• Patients ASA I, II or III and adequate hematological, renal and hepatic function;
• Patients who signed informed consent.

Exclusion Criteria

• Altered cognitive state(eg mental retardation or dementia) that prevents collaboration in the study or patients who can neither read nor write
• Fecal incontinence (Wexner equal to or greater than 6);
• Previous surgery or proctological, colonic and anorectal functional disease
• Diagnosis of synchronous colorectal or any other active neoplasm;
• Patients ASA IV, V;
• Pregnancy and lactation;
• Rejection of the patient to sign the consent form.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Two stage Turnbull-Cutait anastomosis	Ultralow anterior rectal resection with total mesorectal excision	Two staged coloanal anastomosis without protective ileostomy (Turnbull-Cutait procedure).
Coloanal anastomosis with ileostomy	Hand-sewn coloanal anastomosis	Hand-sewn coloanal anastomosis protected by a loop ileostomy
Coloanal anastomosis with ileostomy	Ultralow anterior rectal resection with total mesorectal excision	Hand-sewn coloanal anastomosis protected by a loop ileostomy
Two stage Turnbull-Cutait anastomosis	Two staged Turnbull-Cutait procedure	Two staged coloanal anastomosis without protective ileostomy (Turnbull-Cutait procedure).

Primary Outcome Measures

Name	Time	Method
post-operative morbidity	within the first 30 days after surgery

Secondary Outcome Measures

Name	Time	Method
local and/or distant recurrence of neoplasm	3 years
Quality of life	3 years	by COREFO questionnaire.
Fecal incontinence	3 years	by Wexner Incontinence Score

Trial Locations

Locations (4)

Istituto Nazionale Tumori "Fondazione G, Pascale" - IRCCS; 🇮🇹 Naples, Italy

Vall d'Hebron Universitary Hospital; 🇪🇸 Barcelona, Spain

Corporació Sanitària Parc Taulí Hospital Universitari; 🇪🇸 Sabadell, Barcelona, Spain

Bellvitge University Hospital; 🇪🇸 Barcelona, Spain