Standard versus high definition colonoscopy.

Standard colonoscopy versus high-definition colonoscopy (HD) with/without I-scan functions in the detection of colorectal neoplasia: a randomized multicenter study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20419

Enrollment

1472

Registered

2010-03-30

Start date

2010-04-01

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

adenoma screening colorectal cancer colonoscopy

Interventions

1. Group A: Standard colonoscopes

2. Group B: HD colonoscopes

3. Group C: HD colonoscopes and I-scan Surface Enhancement (SE) (level 4)

4. Group D: HD colonoscopes and I-scan Surface Enhancement (SE) (level 4) and I-scan Colon Mode.

Eligibility

Inclusion criteria

Inclusion criteria: A. One of the following reasons for colonoscopy: 1. Abdominal complaints; 2. Chronic diarrhea; 3. Iron deficiency anemia/ positive fecal occult blood test; 4. (Family) history of adenomatous polyps of colorectal cancer; 5. Screening colonoscopy to prevent CRC. B. Sex: both males and females; C. Age: above 40 years.

Exclusion criteria

Exclusion criteria: 1. Previous extended colon surgery; 2. Inflammatory bowel disease (IBD); 3. Hereditary polyposis syndromes; 4. Known gastrointestinal neoplasia before endoscopy (based on recent endoscopy or other imaging like CT).

Design outcomes

Primary

Measure	Time frame
Adenoma detection rate (ADR): The total number of adenomatous lesions (histological proven) divided by the number of patients per arm in all four groups.	—

Secondary

Measure	Time frame
1. The total number of polyps (adenomatous polyps, hyperplastic polyps, serrated adenomas and inflammatory polyps); 2. The total number and percentage of non-polypoid or flat adenomas (Paris classification 0-IIa-c); 3. Proportion of patients with adenoma; 4. Proportion of patients with more than one polyp; 5. The total number and percentage of small polypoid (< 5mm) or flat lesions (height < ½ diameter); 6. The total number of advanced adenoma defined as adenoma with high grade dysplasia, villous components, intramucosal carcinoma and angio-invasive growth; 7. Number of missed lesions. This will be assessed after a follow up period of 60 months. Patients will be asked by a questionnaire whether they have had any colonoscopy within 60 months of the study period and if so, if any (pre)malignant lesions are found.	—

Measure

Time frame

1. The total number of polyps (adenomatous polyps, hyperplastic polyps, serrated adenomas and inflammatory polyps); 2. The total number and percentage of non-polypoid or flat adenomas (Paris classification 0-IIa-c); 3. Proportion of patients with adenoma; 4. Proportion of patients with more than one polyp; 5. The total number and percentage of small polypoid (< 5mm) or flat lesions (height < ½ diameter); 6. The total number of advanced adenoma defined as adenoma with high grade dysplasia, villous components, intramucosal carcinoma and angio-invasive growth; 7. Number of missed lesions. This will be assessed after a follow up period of 60 months. Patients will be asked by a questionnaire whether they have had any colonoscopy within 60 months of the study period and if so, if any (pre)malignant lesions are found.

—

Contacts

Public ContactR.J.J. Ridder, de

PObox 5800

r.de.ridder@mumc.nl+31 (0)43 3875021

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)