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

This study is currently recruiting participants.
Verified February 2017 by Sebastiano Biondo, Hospital Universitari de Bellvitge
Sponsor:
ClinicalTrials.gov Identifier:
NCT01766661
First Posted: January 11, 2013
Last Update Posted: March 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sebastiano Biondo, Hospital Universitari de Bellvitge
  Purpose
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.

Condition Intervention
Rectal Neoplasm Procedure: Hand-sewn coloanal anastomosis Procedure: Two staged Turnbull-Cutait procedure Procedure: Ultralow anterior rectal resection with total mesorectal excision

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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

Further study details as provided by Sebastiano Biondo, Hospital Universitari de Bellvitge:

Primary Outcome Measures:
  • post-operative morbidity [ Time Frame: within the first 30 days after surgery ]

Secondary Outcome Measures:
  • quality of life [ Time Frame: 3 years ]
    by COREFO questionnaire.

  • Fecal incontinence [ Time Frame: 3 years ]
    by Wexner Incontinence Score

  • local and/or distant recurrence of neoplasm [ Time Frame: 3 years ]

Estimated Enrollment: 92
Study Start Date: January 2013
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Coloanal anastomosis with ileostomy
Hand-sewn coloanal anastomosis protected by a loop ileostomy
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.
Procedure: Ultralow anterior rectal resection with total mesorectal excision
Standard ultralow anterior rectal resection with total mesorectal excision
Experimental: Two stage Turnbull-Cutait anastomosis
Two staged coloanal anastomosis without protective ileostomy (Turnbull-Cutait procedure).
Procedure: 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.
Procedure: Ultralow anterior rectal resection with total mesorectal excision
Standard ultralow anterior rectal resection with total mesorectal excision

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01766661


Contacts
Contact: Sebastiano Biondo, MD, PhD +34 932607500 ext 8107 sbn.biondo@gmail.com

Locations
Italy
Istituto Nazionale Tumori "Fondazione G, Pascale" - IRCCS Recruiting
Naples, Italy, 80131
Contact: Giovanni Romano, MD, PhD       gromano53@katamail.com   
Spain
Vall d'Hebron Universitary Hospital Recruiting
Barcelona, Spain, 08035
Contact: Eloy Espin, MD, PhD    +34 934 89 30 00    eespin@me.com   
Bellvitge University Hospital Recruiting
Barcelona, Spain, 08907
Contact: Loris Trenti, MD    +34 932607500 ext 8107    loris.trenti@bellvitgehospital.cat   
Sponsors and Collaborators
Hospital Universitari de Bellvitge
Investigators
Principal Investigator: Sebastiano Biondo, MD, Phd Bellvitge University Hospital
  More Information

Responsible Party: Sebastiano Biondo, PhD, MD, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT01766661     History of Changes
Other Study ID Numbers: TURNBULL-BCN-01
PR174/11 ( Other Identifier: CEIC Hospital Universitari de Bellvitge )
First Submitted: January 10, 2013
First Posted: January 11, 2013
Last Update Posted: March 1, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Postoperative Complications
Rectal Neoplasms
Pathologic Processes
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases