9 Minutes for Colonoscopy Withdrawal

Not Applicable

Completed

• Conditions: Colorectal Adenomas; Colon Polyps

• Registration Number: NCT03399045
• Lead Sponsor: Changhai Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-08
• Study First Submitted QC: 2018-01-08
• Study First Posted: 2018-01-16
• Study Start: 2018-01-20
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-06
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-27
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1027

Inclusion Criteria

• Patients whose age is between 40-85.
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
adenoma detection rate(ADR)	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 Outcome Measures

Name	Time	Method
adenomas per colonoscopy(APC)	30mins	APC was calculated as the number of adenomas detected during colonoscopy withdraw divided by the number of colonoscopies.

Trial Locations

Locations (1)

Changhai Hospital, Second Military Medical University; 🇨🇳 Shanghai, China