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Colonoscopy with EndoCuff vs conventional colonoscopy A randomized controlled trial

Colonoscopy with EndoCuff vs conventional colonoscopy A randomized controlled trial - EndoCuff trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON39964
Enrollment
1058
Registered
2013-04-17
Start date
2013-08-19
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

colonic polyp colorectal adenoma precursor coloncancer

Interventions

None listed

Sponsors

Stichting Procolo, centrum voor dikkedarmonderzoek
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: *Aged 45 years and older *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 *Signed written informed consent *ASA class I, II or III

Exclusion criteria

Exclusion criteria: *Polyposis syndromes *Inflammatory bowel disease (active disease or surveillance) *Previous partial colonic resection *Known conditions that require the use of a paediatric colonoscope (severe diverticulosis or abdominal surgery in the medical history) *Colonoscopy after polyp detection with CT-colonography *Known colonic stricture *Any acute indication for colonoscopy

Design outcomes

Primary

MeasureTime frame
Mean number of adenomas per patient Adenoma detection rate (percentage of colonoscopies where at least one adenoma is found)

Secondary

MeasureTime frame
* Polyp detection rate & number of polyps per patient * Flat adenoma detection rate * Polyp retrieval rate * Cecal intubation rate and cecal intubation time * Discomfort during the procedure using the Gloucester Comfort scale * Subjective difficulty of the procedure as assessed by the endoscopist * Complication rate

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)