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Colonoscopy with EndoCuff vs conventional colonoscopy: A randomized controlled trial.


- candidate number14774
- NTR NumberNTR3962
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-apr-2013
- Secondary IDs42327 ABR
- Public TitleColonoscopy with EndoCuff vs conventional colonoscopy: A randomized controlled trial.
- Scientific TitleColonoscopy with EndoCuff vs conventional colonoscopy: A randomized controlled trial.
- ACRONYMEndocuff trial
- hypothesisEndocuff colonoscopy will increase the number of adenomas detected.
- Healt Condition(s) or Problem(s) studiedColonoscopy, Colorectal cancer, Adenomas
- Inclusion criteria1. Aged 45 years and older;
2. Scheduled for colonoscopy for on of the following indications: polyp surveillance, changed bowel habits and/or bloody stools or bowel complaints, FOBT+ screening, positive family history for CRC, abdominal pain;
3. Signed written informed consent;
4. ASA class I or II.
- Exclusion criteria1. Polyposis syndromes;
2. Inflammatory bowel disease (active disease or surveillance);
3. Previous partial colonic resection;
4. Known diverticulosis;
5. Colonoscopy after polyp detection with CT-colonography;
6. Known colonic stricture;
7. Any acute indication for colonoscopy.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2013
- planned closingdate1-mei-2014
- Target number of participants972
- InterventionsColonoscopy with Endocuff or conventional colonoscopy.
- Primary outcome1. Mean number of adenomas per patient;
2. Adenoma detection rate (percentage of colonoscopies where at least one adenoma is found).
- Secondary outcome1. Polyp detection rate & number of polyps per patient;
2. Flat adenoma detection rate;
3. Polyp retrieval rate;
4. Cecal intubation rate and cecal intubation time;
5. Discomfort during the procedure using the Gloucester Comfort scale;
6. Subjective difficulty of the procedure as assessed by the endoscopist;
7. Complication rate.
- TimepointsDuring all colonoscopies during the trial data will be collected. After all patients are included (end of study) the primary and secondary outcomes will be measured.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. dr. J.J.G.H.M. Bergman
- CONTACT for SCIENTIFIC QUERIESProf. dr. J.J.G.H.M. Bergman
- Sponsor/Initiator Academic Medical Center (AMC, Amsterdam)
- Funding
(Source(s) of Monetary or Material Support)
ARC Endocuff bv, UK
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD19-apr-2013 - 15-jun-2013


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