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

Colorectal Cancer Clinical Trial

Official title:

Assessing Effect of Withdrawal Time on Adenoma Detection Rate for Screening Colonoscopy: A Randomized Tandem Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05018325
• Other study ID #: 202103025
• Status: Terminated
• Phase: N/A
• Start date: August 30, 2021
• Est. completion date: August 19, 2022

Study information

• Verified date: August 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: August 19, 2022
• Est. primary completion date: August 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Adenoma
• Colon Cancer
• Colorectal Cancer
• Rectal Cancer

Intervention

Procedure:
• Colonoscopy with 6 minute withdrawal
Withdrawal time will be determined using a digital stopwatch by the nursing staff.
• Colonoscopy 9 minute withdrawal
Withdrawal time will be determined using a digital stopwatch by the nursing staff.
• Colonoscopy 12 minute withdrawal
Withdrawal time will be determined using a digital stopwatch by the nursing staff.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Miss rate of polyps	Miss rate = missed polyps/missed polyps + polyps found during 1st exam; Polyps is defined as adenomas and sessile serrated adenomas (SSA)	Time of colonoscopy (day 1)
Secondary	Miss rate of advanced adenomas	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	Time of colonoscopy (day 1)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine