Familial adenomatous polyposis (FAP) heriditary colon cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosis of FAP - Genetic diagnosis: proven APC germline mutation - Clinical diagnosis: >100 colorectal adenomas in combination with a positive family history of FAP Have an ileal-pouch anal anastomosis (IPAA) - After primary proctocolectomy or - secondary protectomy after initial colectomy with ileorectal or ileosigmoidal anastomosis (IRA/ISA) Age >= 18 years.
Exclusion criteria
Exclusion criteria: Allergy to indigo carmine (fluid which is used with dye chromoendoscopy). Patients who are unwilling or unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this study is the detection of clinical relevant adenomas (>= 5mm) in the ileal pouch. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include: - Detection of advanced neoplasia in the ileal pouch, defined by advanced adenoma (>=10mm and/or and adenoma with high-grade dysplasia) or cancer. - Detection of adenomas 1-4mm, 5-9mm and >=10mm both in the pouch body and rectal remnant with WLE, NBI and dye-based chromoendoscopy - Number of performed polypectomies - Chosen interval for next surveillance endoscopy - Insight Polyposis Staging System (IPSS) score (10) - Duration of examination - Incidence of endoscopy-related complications | — |
Countries
Netherlands