Study of Two Techniques of Rectal Reservoir in Low Anterior Resection of Rectum

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. Read our disclaimer for details. Identifier: NCT01396928
Recruitment Status : Completed
First Posted : July 19, 2011
Last Update Posted : October 2, 2012
Information provided by:
Hospital Universitari de Bellvitge

Brief Summary:
The aim of the study CGD-01/2000 was to investigate wheter a transverse coloplasty pouch is able to improve functional results and quality of life after coloanal anastomosis.

Condition or disease Intervention/treatment
Low Rectal Adenocarcinoma Procedure: Colonic reservoir

Study Type : Observational
Actual Enrollment : 106 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Randomized Study of Two Techniques of Rectal Reservoir in Low Anterior Resection of Rectum
Study Start Date : November 2000
Actual Primary Completion Date : December 2005
Actual Study Completion Date : July 2010

Group/Cohort Intervention/treatment
"J" pouch
Anastomosis coloanal wiht "j" pouch reservoir
Procedure: Colonic reservoir
Type of reservoir to be performed
Transverse coloplasty pouch
Coloanal anastomosis with transverse coloplasty pouch reservoir
Procedure: Colonic reservoir
Type of reservoir to be performed

Primary Outcome Measures :
  1. Quality of life [ Time Frame: five years ]
    Functional results and quality of life after coloanal anastomosis with colonic reservoir

Secondary Outcome Measures :
  1. Morbidity and cost-effectiveness [ Time Frame: 30 days ]
    Investigate if the new technique is more easily, quickly and cheap.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients wiht low or middle rectal adenocarcinoma after neoadyuvant radio-chemotherapy

Inclusion Criteria:

  • Low or middle rectal adenocarcinoma without involvement of the anal sphincter
  • Neoadjuvant chemoradiotherapy
  • Age older than 18 years
  • Wexner index of less than 5
  • Signed informed consent

Exclusion Criteria:

  • Involvement of the anal sphincter
  • Wexner index of 5 or more
  • Declined informed consent
  • Psychological or social problems

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sebastiano Biondo, MD, Barcelona University Identifier: NCT01396928     History of Changes
Other Study ID Numbers: CGD-01/2000
First Posted: July 19, 2011    Key Record Dates
Last Update Posted: October 2, 2012
Last Verified: November 2000

Keywords provided by Hospital Universitari de Bellvitge:
Low rectal adenocarcinoma

Additional relevant MeSH terms:
Rectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases