The efficacy of cap-assisted colonoscopy compared with regular colonoscopy in CRC screening participants.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29640

Enrollment

1250

Registered

2009-06-30

Start date

2009-07-03

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

adenoma, cap-assisted colonoscopy

Interventions

For this study, all individuals who participate in the pilot study for populationscreening for CRC by direct colonoscopy will be randomized in two different arms: 1. Cap-assisted colonoscopy

2. Regular colonoscopy. A total number of 5000 individuals will be invited for our screening program. We expect a participation rate of 25 %, resulting in 1250 participants, 625 individuals in each a

Eligibility

Inclusion criteria

Inclusion criteria: 1. Asymptomatic individuals between 50 and 74 years of age, undergoing scheduled screening colonoscopy; 2. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Participants in previous CRC population screening trials; 2. Complete colonoscopy performed within the last 5 years; 3. Personal history of colonic adenomas or colorectal cancer; 4. Longstanding IBD; 5. Severe or terminal disease (life-expectancy < 5 years); 6. Inability or refusal to provide informed consent.

Design outcomes

Primary

Measure	Time frame
1. Percentage of patients with adenomas detected with cap-assisted colonoscopy compared to regular colonoscopy; 2. Adenoma detection rate of cap-assisted colonoscopy compared to regular colonoscopy.	—

Secondary

Measure	Time frame
1. Percentage of patients with polyps detected with cap-assisted colonoscopy compared to regular colonoscopy; 2. Polyp detection rate of cap-assisted colonoscopy compared with regular colonoscopy; 3. Cecal intubation times and rates in cap-assisted colonoscopy compared to regular colonoscopy; 4. Polypectomy time of cap-assisted colonoscopy compared to regular colonoscopy; 5. Difficulty of the colonoscopy and polypectomy procedure in cap-assisted colonoscopy compared to regular colonoscopy; 6. The burden of colonoscopy in cap-assisted colonoscopy compared to regular colonoscopy; 7. Complication rates of cap-assisted colonoscopy and regular colonoscopy;	—

Measure

Time frame

1. Percentage of patients with polyps detected with cap-assisted colonoscopy compared to regular colonoscopy; 2. Polyp detection rate of cap-assisted colonoscopy compared with regular colonoscopy; 3. Cecal intubation times and rates in cap-assisted colonoscopy compared to regular colonoscopy; 4. Polypectomy time of cap-assisted colonoscopy compared to regular colonoscopy; 5. Difficulty of the colonoscopy and polypectomy procedure in cap-assisted colonoscopy compared to regular colonoscopy; 6. The burden of colonoscopy in cap-assisted colonoscopy compared to regular colonoscopy; 7. Complication rates of cap-assisted colonoscopy and regular colonoscopy;

—

Contacts

Public ContactT.R. de Wijkerslooth

Dept of Gastroenterology & Hepatology C2-231 Academic Medical Centre Meibergdreef 9

t.r.dewijkerslooth@amc.uva.nl+31.20.5666464

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)