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

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

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.

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer; Rectal Cancer; Colon Cancer
• Intervention / Treatment: Procedure: Colonoscopy with 6 minute withdrawal; Procedure: Colonoscopy 9 minute withdrawal; Procedure: Colonoscopy 12 minute withdrawal

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1: Colonoscopy 6 minute withdrawal time; -Undergo colonoscopy with the standard 6-minute withdrawal time followed by a tandem colonoscopy of at least another 6-minute withdrawal time.	Procedure: Colonoscopy with 6 minute withdrawal; Withdrawal time will be determined using a digital stopwatch by the nursing staff.
Experimental: Arm 2: Colonoscopy 9 minute withdrawal time; -Undergo a 9-minute withdrawal time followed by a tandem colonoscopy with at least the standard 6-minute withdrawal time.	Procedure: Colonoscopy 9 minute withdrawal; Withdrawal time will be determined using a digital stopwatch by the nursing staff.
Experimental: Arm 3: Colonoscopy 12 minute withdrawal time; -Undergo colonoscopy with a 12-minute withdrawal time followed by a tandem colonoscopy with at least the standard 6-minute withdrawal time	Procedure: Colonoscopy 12 minute withdrawal; Withdrawal time will be determined using a digital stopwatch by the nursing staff.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2021
• Primary Completion (Actual): August 19, 2022
• Study Completion (Actual): August 19, 2022

Study Registration Dates

• First Submitted: August 12, 2021
• First Submitted That Met QC Criteria: August 17, 2021
• First Posted (Actual): August 24, 2021

Study Record Updates

• Last Update Posted (Actual): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 26, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: 202103025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual participant data that underline the results reported, after deidentification.
• IPD Sharing Time Frame: Immediately following publication without an end date
• IPD Sharing Access Criteria: Anyone who wishes to access the data.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No