Colorectal Neoplasms Clinical Trial
Official title:
Impact of Screen Size on Colorectal Adenoma Detection Rate: a Single Centre Randomised Controlled Trial
NCT number | NCT04749303 |
Other study ID # | 2020.327 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2020 |
Est. completion date | August 31, 2021 |
Verified date | February 2021 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to assess whether the use of large screen during colonoscopy will increase adenoma detection rate.
Status | Recruiting |
Enrollment | 656 |
Est. completion date | August 31, 2021 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - Patients aged 18 years or above - Referred to the endoscopy unit for diagnostic or surveillance colonoscopy Exclusion Criteria: - Familial history of Familial adenomatous polyposis or Hereditary non-polyposis colorectal cancer - Known history of inflammatory bowel disease - Emergency endoscopy of any nature (such as for gastrointestinal bleeding, assessment of large bowel investigation and colonic decompression) - Patients with colostomy - Previously incomplete colonoscopy (not including insufficient preparation) - Patients with known palliative colorectal malignant disease Patients with coagulopathies Inability to give informed consent |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Prince of Wales Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adenoma Detection Rate (ADR) | ADR is defined as the proportion of an endoscopist's screening colonoscopies in which one or more adenomas have been detected in patients | 12 months | |
Secondary | Mean number of adenomas detected per colonoscopy | Mean number of adenomas detected per colonoscopy found in each arm | 12 months | |
Secondary | Mean number of sessile serrated polyps | Mean number of sessile serrated polyps found in each arm | 12 months | |
Secondary | Caecal intubation rate | percentage of caecal intubation rate in each arm | 12 months | |
Secondary | Bowel cleansing level | According to the Boston bowel preparation scale (0=worst bowel preparation to 9= best bowel preparation). Comparison of each arm. | 12 months | |
Secondary | Procedure Time | Both intubation and withdrawal time will be recorded. Comparison of each arm. | 12 months | |
Secondary | Severe adverse events | SAEs of both arms for comparisons | 12 months |
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