Prospective Randomized Study of Two Techniques of Rectal Reservoir in Low Anterior Resection of Rectum
Phase 2/Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Low Rectal Adenocarcinoma
Both
Low Rectal Adenocarcinoma
Trial Information
Prospective Randomized Study of Two Techniques of Rectal Reservoir in Low Anterior Resection of Rectum
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Quality of life
Outcome Description:
Functional results and quality of life after coloanal anastomosis with colonic reservoir
Outcome Time Frame:
five years
Safety Issue:
Yes
Authority:
Spain: Hospital Universitari de Bellvitge
Study ID:
CGD-01/2000
NCT ID:
NCT01396928
Start Date:
November 2000
Completion Date:
July 2010
Related Keywords:
- Low Rectal Adenocarcinoma
- Low rectal adenocarcinoma
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Rectal Neoplasms
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