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Prospective Multicenter Randomized Controlled Trial On Two-Stage Turnbull-Cutait Coloanal Anastomosis For Rectal (TURNBULL-BCN)

Primary Purpose

Rectal Neoplasm

Status

Unknown status

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Hand-sewn coloanal anastomosis

Two staged Turnbull-Cutait procedure

Ultralow anterior rectal resection with total mesorectal excision

About this trial

This is an interventional supportive care trial for Rectal Neoplasm

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Istituto Nazionale Tumori "Fondazione G, Pascale" - IRCCS
Corporació Sanitària Parc Taulí Hospital Universitari
Vall d'Hebron Universitary Hospital
Bellvitge University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Coloanal anastomosis with ileostomy

Two stage Turnbull-Cutait anastomosis

Arm Description

Hand-sewn coloanal anastomosis protected by a loop ileostomy

Two staged coloanal anastomosis without protective ileostomy (Turnbull-Cutait procedure).

Outcomes

Primary Outcome Measures

post-operative morbidity

Secondary Outcome Measures

Quality of life

by COREFO questionnaire.

Fecal incontinence

by Wexner Incontinence Score

local and/or distant recurrence of neoplasm

Full Information

NCT ID

NCT01766661

First Posted

January 10, 2013

Last Updated

February 25, 2019

Sponsor

Hospital Universitari de Bellvitge

1. Study Identification

Unique Protocol Identification Number

NCT01766661

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 2013 (undefined)

Primary Completion Date

March 2019 (Anticipated)

Study Completion Date

February 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Universitari de Bellvitge

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rectal Neoplasm

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

92 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Coloanal anastomosis with ileostomy

Arm Type

Active Comparator

Arm Description

Hand-sewn coloanal anastomosis protected by a loop ileostomy

Arm Title

Two stage Turnbull-Cutait anastomosis

Arm Type

Experimental

Arm Description

Two staged coloanal anastomosis without protective ileostomy (Turnbull-Cutait procedure).

Intervention Type

Procedure

Intervention Name(s)

Hand-sewn coloanal anastomosis

Intervention Description

After low anterior rectal resection due to low rectal neoplasm patients undergo intestinal reconstructions as hand-sewn coloanal anastomosis with protective loop ileostomy.

Intervention Type

Procedure

Intervention Name(s)

Two staged Turnbull-Cutait procedure

Intervention Description

After low anterior rectal resection due to low rectal neoplasm patients undergo intestinal reconstructions as two staged Turnbull-Cutait procedure anastomosis without protective ileostomy.

Intervention Type

Procedure

Intervention Name(s)

Ultralow anterior rectal resection with total mesorectal excision

Intervention Description

Standard ultralow anterior rectal resection with total mesorectal excision

Primary Outcome Measure Information:

Title

post-operative morbidity

Time Frame

within the first 30 days after surgery

Secondary Outcome Measure Information:

Title

Quality of life

Description

by COREFO questionnaire.

Time Frame

3 years

Title

Fecal incontinence

Description

by Wexner Incontinence Score

Time Frame

3 years

Title

local and/or distant recurrence of neoplasm

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sebastiano Biondo, MD, Phd

Organizational Affiliation

Bellvitge University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Istituto Nazionale Tumori "Fondazione G, Pascale" - IRCCS

City

Naples

ZIP/Postal Code

80131

Country

Italy

Facility Name

Corporació Sanitària Parc Taulí Hospital Universitari

City

Sabadell

State/Province

Barcelona

Country

Spain

Facility Name

Vall d'Hebron Universitary Hospital

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Bellvitge University Hospital

City

Barcelona

ZIP/Postal Code

08907

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

32492131

Citation

Biondo S, Trenti L, Espin E, Bianco F, Barrios O, Falato A, De Franciscis S, Solis A, Kreisler E; TURNBULL-BCN Study Group. Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis for Low Rectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2020 Aug 1;155(8):e201625. doi: 10.1001/jamasurg.2020.1625. Epub 2020 Aug 19.

Results Reference

derived

PubMed Identifier

28667499

Citation

Biondo S, Trenti L, Galvez A, Espin-Basany E, Bianco F, Romano G, Kreisler E; Turnbull-BCN study group. 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.

Results Reference

derived

Learn more about this trial

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

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