Prospective Multicenter Randomized Controlled Trial On Two-Stage Turnbull-Cutait Coloanal Anastomosis For Rectal
TURNBULL-BCN
2 other identifiers
interventional
92
2 countries
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2013
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 10, 2013
CompletedFirst Posted
Study publicly available on registry
January 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedFebruary 27, 2019
February 1, 2019
6.2 years
January 10, 2013
February 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
post-operative morbidity
within the first 30 days after surgery
Secondary Outcomes (3)
Quality of life
3 years
Fecal incontinence
3 years
local and/or distant recurrence of neoplasm
3 years
Study Arms (2)
Coloanal anastomosis with ileostomy
ACTIVE COMPARATORHand-sewn coloanal anastomosis protected by a loop ileostomy
Two stage Turnbull-Cutait anastomosis
EXPERIMENTALTwo staged coloanal anastomosis without protective ileostomy (Turnbull-Cutait procedure).
Interventions
After low anterior rectal resection due to low rectal neoplasm patients undergo intestinal reconstructions as hand-sewn coloanal anastomosis with protective loop ileostomy.
After low anterior rectal resection due to low rectal neoplasm patients undergo intestinal reconstructions as two staged Turnbull-Cutait procedure anastomosis without protective ileostomy.
Standard ultralow anterior rectal resection with total mesorectal excision
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Istituto Nazionale Tumori "Fondazione G, Pascale" - IRCCS
Naples, 80131, Italy
Corporació Sanitària Parc Taulí Hospital Universitari
Sabadell, Barcelona, Spain
Vall d'Hebron Universitary Hospital
Barcelona, 08035, Spain
Bellvitge University Hospital
Barcelona, 08907, Spain
Related Publications (3)
Biondo S, Barrios O, Trenti L, Espin E, Bianco F, Falato A, De Franciscis S, Solis A, Kreisler E; TURNBULL-BCN Study Group. Long-Term Results of 2-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis for Low Rectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2024 Sep 1;159(9):990-996. doi: 10.1001/jamasurg.2024.2262.
PMID: 38985480DERIVEDBiondo 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.
PMID: 32492131DERIVEDBiondo 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.
PMID: 28667499DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sebastiano Biondo, MD, Phd
Bellvitge University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, MD
Study Record Dates
First Submitted
January 10, 2013
First Posted
January 11, 2013
Study Start
January 1, 2013
Primary Completion
March 1, 2019
Study Completion
February 1, 2022
Last Updated
February 27, 2019
Record last verified: 2019-02