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

Rectal Neoplasm Clinical Trial

— TURNBULL-BCN  

Official title:

Prospective Multicenter Randomized Controlled Trial Comparing Postoperative Complications and Quality of Life in Low Rectal Cancer Surgery Between Coloanal Anastomosis and Lateral Ileostomy Versus Two-Stage Turnbull-Cutait Coloanal Anastomosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01766661
• Other study ID #: TURNBULL-BCN-01
• Secondary ID: PR174/11
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2013
• Est. completion date: February 2022

Study information

• Verified date: February 2019
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 92
• Est. completion date: February 2022
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Postoperative Complications
• Rectal Neoplasm
• Rectal Neoplasms

Intervention

Procedure:
• Hand-sewn coloanal anastomosis
After low anterior rectal resection due to low rectal neoplasm patients undergo intestinal reconstructions as hand-sewn coloanal anastomosis with protective loop ileostomy.
• Two staged Turnbull-Cutait procedure
After low anterior rectal resection due to low rectal neoplasm patients undergo intestinal reconstructions as two staged Turnbull-Cutait procedure anastomosis without protective ileostomy.
• Ultralow anterior rectal resection with total mesorectal excision
Standard ultralow anterior rectal resection with total mesorectal excision

Locations

Country	Name	City	State
Italy	Istituto Nazionale Tumori "Fondazione G, Pascale" - IRCCS	Naples
Spain	Bellvitge University Hospital	Barcelona
Spain	Vall d'Hebron Universitary Hospital	Barcelona
Spain	Corporació Sanitària Parc Taulí Hospital Universitari	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge

Countries where clinical trial is conducted

Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post-operative morbidity		within the first 30 days after surgery
Secondary	Quality of life	by COREFO questionnaire.	3 years
Secondary	Fecal incontinence	by Wexner Incontinence Score	3 years
Secondary	local and/or distant recurrence of neoplasm		3 years