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

The Washington University

Status: Terminated

Conditions: Colon Cancer; Colorectal Cancer; Rectal Cancer

Treatments: Procedure: Colonoscopy with 6 minute withdrawal; Procedure: Colonoscopy 12 minute withdrawal; Procedure: Colonoscopy 9 minute withdrawal

Study type: Interventional

Funder types: Other

Identifiers

NCT05018325

202103025

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 3 patient groups

Arm 1: Colonoscopy 6 minute withdrawal time

Active Comparator group

Description:

-Undergo colonoscopy with the standard 6-minute withdrawal time followed by a tandem colonoscopy of at least another 6-minute withdrawal time.

Treatment:

Procedure: Colonoscopy with 6 minute withdrawal

Arm 2: Colonoscopy 9 minute withdrawal time

Experimental group

Description:

-Undergo a 9-minute withdrawal time followed by a tandem colonoscopy with at least the standard 6-minute withdrawal time.

Treatment:

Procedure: Colonoscopy 9 minute withdrawal

Arm 3: Colonoscopy 12 minute withdrawal time

Experimental group

Description:

-Undergo colonoscopy with a 12-minute withdrawal time followed by a tandem colonoscopy with at least the standard 6-minute withdrawal time

Treatment:

Procedure: Colonoscopy 12 minute withdrawal