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
|
Type of reservoir to be performed
|
|
Transverse coloplasty pouch
Coloanal anastomosis with transverse coloplasty pouch 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.
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.
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.