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

Primary Purpose

Colon Cancer, Rectal Cancer, Colorectal Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Colonoscopy with 6 minute withdrawal
Colonoscopy 9 minute withdrawal
Colonoscopy 12 minute withdrawal
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colon Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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).

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Arm 1: Colonoscopy 6 minute withdrawal time

Arm 2: Colonoscopy 9 minute withdrawal time

Arm 3: Colonoscopy 12 minute withdrawal time

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
August 12, 2021
Last Updated
August 26, 2022
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05018325
Brief Title
Assessing Effect of Withdrawal Time on Adenoma Detection Rate for Screening Colonoscopy
Official Title
Assessing Effect of Withdrawal Time on Adenoma Detection Rate for Screening Colonoscopy: A Randomized Tandem Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
Futility
Study Start Date
August 30, 2021 (Actual)
Primary Completion Date
August 19, 2022 (Actual)
Study Completion Date
August 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Rectal Cancer, Colorectal Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Colonoscopy 6 minute withdrawal time
Arm Type
Active Comparator
Arm Description
-Undergo colonoscopy with the standard 6-minute withdrawal time followed by a tandem colonoscopy of at least another 6-minute withdrawal time.
Arm Title
Arm 2: Colonoscopy 9 minute withdrawal time
Arm Type
Experimental
Arm Description
-Undergo a 9-minute withdrawal time followed by a tandem colonoscopy with at least the standard 6-minute withdrawal time.
Arm Title
Arm 3: Colonoscopy 12 minute withdrawal time
Arm Type
Experimental
Arm Description
-Undergo colonoscopy with a 12-minute withdrawal time followed by a tandem colonoscopy with at least the standard 6-minute withdrawal time
Intervention Type
Procedure
Intervention Name(s)
Colonoscopy with 6 minute withdrawal
Intervention Description
Withdrawal time will be determined using a digital stopwatch by the nursing staff.
Intervention Type
Procedure
Intervention Name(s)
Colonoscopy 9 minute withdrawal
Intervention Description
Withdrawal time will be determined using a digital stopwatch by the nursing staff.
Intervention Type
Procedure
Intervention Name(s)
Colonoscopy 12 minute withdrawal
Intervention Description
Withdrawal time will be determined using a digital stopwatch by the nursing staff.
Primary Outcome Measure Information:
Title
Miss rate of polyps
Description
Miss rate = missed polyps/missed polyps + polyps found during 1st exam Polyps is defined as adenomas and sessile serrated adenomas (SSA)
Time Frame
Time of colonoscopy (day 1)
Secondary Outcome Measure Information:
Title
Miss rate of advanced adenomas
Description
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 Frame
Time of colonoscopy (day 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimir Kushnir, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

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

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