Assessing Effect of Withdrawal Time on Adenoma Detection Rate for Screening Colonoscopy

Not Applicable

Terminated

• Conditions: Rectal Cancer; Colon Cancer; Colorectal Cancer
• Interventions: Procedure: Colonoscopy 9 minute withdrawal; Procedure: Colonoscopy 12 minute withdrawal; Procedure: Colonoscopy with 6 minute withdrawal

• Registration Number: NCT05018325
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The investigators' null hypothesis is that a withdrawal time of 9 to 10 minutes is non-inferior to a withdrawal time of 12 minutes or greater. Thus, the goal of this tandem design trial is to compare the additional diagnostic yield (# of missed lesions) for withdrawal times exceeding 10 minutes for screening/surveillance colonoscopies. Although withdrawal times longer than the standard 6-minute recommendation have been shown to be beneficial, there is limited prospective evidence investigating the benefit or lack thereof for withdrawal times greater than 9-10 minutes.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-12
• Study First Submitted QC: 2021-08-17
• Study First Posted: 2021-08-24
• Study Start: 2021-08-30
• Status Verified: 2022-08
• Primary Completion: 2022-08-19
• Study Completion: 2022-08-19
• Last Update Submitted: 2022-08-26
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Must be between the ages of 18 and 75 years
• Must be a patient undergoing screening or surveillance colonoscopy
• Must be able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria

• Inability to provide informed consent.
• Personal history of colorectal cancer (CRC)
• Personal history of colon surgery or colon resection
• Personal history of Inflammatory bowel disease
• Personal history of familial polyposis
• Current pregnancy
• Active GI bleeding
• Colonoscopy exams where the cecum cannot be reached (randomization will occur after cecum is reached).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2: Colonoscopy 9 minute withdrawal time	Colonoscopy 9 minute withdrawal	-Undergo a 9-minute withdrawal time followed by a tandem colonoscopy with at least the standard 6-minute withdrawal time.
Arm 3: Colonoscopy 12 minute withdrawal time	Colonoscopy 12 minute withdrawal	-Undergo colonoscopy with a 12-minute withdrawal time followed by a tandem colonoscopy with at least the standard 6-minute withdrawal time
Arm 1: Colonoscopy 6 minute withdrawal time	Colonoscopy with 6 minute withdrawal	-Undergo colonoscopy with the standard 6-minute withdrawal time followed by a tandem colonoscopy of at least another 6-minute withdrawal time.

Primary Outcome Measures

Name	Time	Method
Miss rate of polyps	Time of colonoscopy (day 1)	* Miss rate = missed polyps/missed polyps + polyps found during 1st exam; * Polyps is defined as adenomas and sessile serrated adenomas (SSA)

Secondary Outcome Measures

Name	Time	Method
Miss rate of advanced adenomas	Time of colonoscopy (day 1)	* Miss rate = missed advanced adenomas/missed advanced adenomas + advanced adenomas found during 1st exam; * Advanced adenoma defined as a polyp ≥ 10mm, adenomas with high-grade dysplasia or villous architecture, serrated lesions with dysplasia, or traditional serrated adenomas

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States