Impact of 9-minute Withdrawal Time on Adenoma Detection Rate：a Multicenter, Prospective, Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Changhai Hospital
- Enrollment
- 1,027
- Locations
- 1
- Primary Endpoint
- adenoma detection rate(ADR)
Study Overview
Brief Summary
A withdrawal time of at least 6 minutes has been considered to be necessary to guarantee the adenoma detection rate and the critical quality criterion of colonoscopy. However, several large observational investigations demonstrated that 9 minutes will be in favor of higher adenoma detection rate and lower risk of interval colorectal cancer, when compared with 6-minute withdrawal. Meanwhile, a few studies also indicated that no significant benefit were observed in longer withdrawal time. Up to now, no randomized controlled trials have been conducted to give a definitive conclusion. Therefore, we performed a multicenter, prospective, randomized Controlled trial to compare adenoma detection rate of 6-minute and 9-minute withdrawal in colonoscopy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients whose age is between 40-
- •Patients who have indications for screening, surveillance and diagnostic colonoscopy.
- •Patients who have signed inform consent form
Exclusion Criteria
- •Patients who have undergone colonic resection
- •Patients with intracranial and/or central nervous system disease, including cerebral infarction and cerebral hemorrhage.
- •Patients with severe chronic cardiopulmonary and renal disease.
- •Patients who are unwilling or unable to consent.
- •Patients who are not suitable for colonoscopy
- •Patients who received urgent or therapeutic colonoscopy
- •Patients with pregnancy, inflammatory bowel disease, polyposis of colon, colorectal cancer, or intestinal obstruction
- •Patients who are taking aspirin, clopidogrel or other anticoagulants
- •Patients with Aronchick score > 3
Outcomes
Primary Outcomes
adenoma detection rate(ADR)
Time Frame: 30mins
ADR was calculated adenoma detection rate is the number of patients with at least one adenoma, divided by the total number of patients.
Secondary Outcomes
- adenomas per colonoscopy(APC)(30mins)
Investigators
Zhaoshen Li
Director of Gastroenterology Dept
Changhai Hospital