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Safety of a long-term endoscopic surveillance protocol for serrated polyposis patients


- candidate number17942
- NTR NumberNTR4609
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-mei-2014
- Secondary IDs10.17.2005 METC AMC
- Public TitleSafety of a long-term endoscopic surveillance protocol for serrated polyposis patients
- Scientific TitleSafety of a long-term endoscopic surveillance protocol for serrated polyposis patients
- ACRONYM
- hypothesisTo prospectively assess the efficacy, feasibility and safety of a renewed systemised endoscopic surveillance protocol in large multicentre HPS cohort.
- Healt Condition(s) or Problem(s) studiedColorectal cancer, Serrated polyposis syndrome
- Inclusion criteriaHPS patients defined as:
> 5 HPs/SSA proximal to the sigmoid, of which 2 > 10 mm in diameter, or more than 20 HPs/SSAs distributed throughout the colon.
- Exclusion criteriaCarriers of a germline mutation in the MutYH or APC gene and individuals who have undergone a total colonic resection.
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2013
- planned closingdate1-jan-2018
- Target number of participants250
- InterventionsData are collected in prospective manner from patients during routine surveillance endoscopies with removal of all polyps > 3 mm and/or with a adenomatous aspect.
- Primary outcome- Incidence of interval colorectal cancer during protocolled endoscopic surveillance of SPS patients
- Secondary outcome- Incidence and characteristics of polyps found during endoscopic surveillance of SPS patients
- The ratio of annual and biennial surveillance advise
- Incidence of conversion to preventive colorectal surgery
- Incidence of post-colonoscopy complications
- Timepoints5 years
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES J.E.G. IJspeert
- CONTACT for SCIENTIFIC QUERIESProf. dr. E. Dekker
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summarySerrated polyposis syndrome (SPS) is characterized by the presence of multiple colorectal serrated polyps and is associated with an increased colorectal cancer (CRC) risk. The prevalance of SPS is estimated to be 1:3000 which makes SPS more common than other polyposis syndromes such as FAP. Due to the risk of malignant polyp transformation, SPS patients undergo endscopic surveillance with removal of polyps or a surgical colonic resection. However, no uniform and adequately substantiated endoscopic management protocol exists regarding polyp removal and surveillance intervals. Earlier research from our research group showed that annual surveillance by experts is safe with regard to interval carcinomas. However annual surveillance could result in systematic overtreatment.

Aim:
To prospectively assess the efficacy, feasibility and safety of a new systemised endoscopic surveillance protocol in which colonoscopic findings will determine the following surveillance interval; one or two years.
- Main changes (audit trail)
- RECORD23-mei-2014 - 22-jun-2014


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