Low Rectal Adenocarcinoma Clinical Trial
Official title:
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.
| Status | Completed |
| Enrollment | 106 |
| Est. completion date | July 2010 |
| Est. primary completion date | December 2005 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hospital Universitari de Bellvitge |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Quality of life | Functional results and quality of life after coloanal anastomosis with colonic reservoir | five years | Yes |
| Secondary | Morbidity and cost-effectiveness | Investigate if the new technique is more easily, quickly and cheap. | 30 days | Yes |