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

Completed

• Conditions: Low Rectal Adenocarcinoma
• Interventions: Procedure: Colonic reservoir

• Registration Number: NCT01396928
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2000-11
• Study Start: 2000-11
• Primary Completion: 2005-12
• Study Completion: 2010-07
• Study First Submitted: 2011-07-18
• Study First Submitted QC: 2011-07-18
• Study First Posted: 2011-07-19
• Last Update Submitted: 2012-10-01
• Last Update Posted: 2012-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
"J" pouch	Colonic reservoir	Anastomosis coloanal wiht "j" pouch reservoir
Transverse coloplasty pouch	Colonic reservoir	Coloanal anastomosis with transverse coloplasty pouch reservoir

Primary Outcome Measures

Name	Time	Method
Quality of life	five years	Functional results and quality of life after coloanal anastomosis with colonic reservoir

Secondary Outcome Measures

Name	Time	Method
Morbidity and cost-effectiveness	30 days	Investigate if the new technique is more easily, quickly and cheap.