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

• Sponsor: Hospital Universitari de Bellvitge (Other)
• Overall Status: Completed
• CT.gov ID: NCT01396928
• Collaborator: (none)
• Enrollment: 106
• Duration (Months): 115.9

Study Details

Study Description

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	Phase
Low Rectal Adenocarcinoma	Procedure: Colonic reservoir

Study Design

• 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: Nov 1, 2000
• Actual Primary Completion Date: Dec 1, 2005
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Quality of life [five years]

   Functional results and quality of life after coloanal anastomosis with colonic reservoir

Secondary Outcome Measures

1. Morbidity and cost-effectiveness [30 days]

   Investigate if the new technique is more easily, quickly and cheap.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hospital Universitari de Bellvitge

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01396928
• Other Study ID Numbers: CGD-01/2000
• First Posted: Jul 19, 2011
• Last Update Posted: Oct 2, 2012
• Last Verified: Nov 1, 2000

• Keywords provided by , ,: Low rectal adenocarcinoma
• Additional relevant MeSH terms: Adenocarcinoma

Study Results

No Results Posted as of Oct 2, 2012