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

October 1, 2012 updated by: Hospital Universitari de Bellvitge

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients wiht low or middle rectal adenocarcinoma after neoadyuvant radio-chemotherapy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: five years
Functional results and quality of life after coloanal anastomosis with colonic reservoir
five years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity and cost-effectiveness
Time Frame: 30 days
Investigate if the new technique is more easily, quickly and cheap.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari de Bellvitge

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2000

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

July 18, 2011

First Submitted That Met QC Criteria

July 18, 2011

First Posted (Estimate)

July 19, 2011

Study Record Updates

Last Update Posted (Estimate)

October 2, 2012

Last Update Submitted That Met QC Criteria

October 1, 2012

Last Verified

November 1, 2000

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGD-01/2000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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