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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20756

Enrollment

972

Registered

2013-04-19

Start date

2013-05-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Colonoscopy with Endocuff or conventional colonoscopy.

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

Measure	Time frame
1. Mean number of adenomas per patient; 2. Adenoma detection rate (percentage of colonoscopies where at least one adenoma is found).	—

Secondary

Measure	Time frame
1. 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.	—

Contacts

Public ContactJ.J.G.H.M. Bergman

Academic Medical Center Bldg. C2-210, Meibergdreef

j.j.bergman@amc.uva.nl+31 (0)20 5669111

Outcome results