Trial Information
Adenoma-Carcinoma Sequence in the Ileal Pouch Anal Anastomosis in Patients With Familial Adenomatous Polyposis: Studies on Luminal and Mucosal Risk Factors and Chemoprevention
Inclusion Criteria:
- Clinically or genetically proven familial adenomatous polyposis
- Restorative proctocolectomy with ileal pouch anal anastomosis
Exclusion Criteria:
- Chronic or acute renal or hepatic disease
- History of oesophageal, gastric or duodenal ulcers
- Known hypersensitivity to sulindac
- Daily use during the last three months of:
- Aspirin
- Non-Steroidal Anti-Inflammatory Agents
- Probiotics
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Pouch mucosal proliferation index at 0, 1 and 2 months
Principal Investigator
Fokko M Nagengast, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Radboud University
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
23266
NCT ID:
NCT00319007
Start Date:
April 2006
Completion Date:
December 2006
Related Keywords:
- Adenomatous Polyposis Coli
- Adenoma
- Adenomatous Polyposis Coli