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

NCT ID: NCT05018325

Last Updated: 2022-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-30

Study Completion Date

2022-08-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colon Cancer Rectal Cancer Colorectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Colonoscopy with 6 minute withdrawal

Intervention Type PROCEDURE

Withdrawal time will be determined using a digital stopwatch by the nursing staff.

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.

Group Type EXPERIMENTAL

Colonoscopy 9 minute withdrawal

Intervention Type PROCEDURE

Withdrawal time will be determined using a digital stopwatch by the nursing staff.

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

Group Type EXPERIMENTAL

Colonoscopy 12 minute withdrawal

Intervention Type PROCEDURE

Withdrawal time will be determined using a digital stopwatch by the nursing staff.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Colonoscopy with 6 minute withdrawal

Withdrawal time will be determined using a digital stopwatch by the nursing staff.

Intervention Type PROCEDURE

Colonoscopy 9 minute withdrawal

Withdrawal time will be determined using a digital stopwatch by the nursing staff.

Intervention Type PROCEDURE

Colonoscopy 12 minute withdrawal

Withdrawal time will be determined using a digital stopwatch by the nursing staff.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Vladimir Kushnir, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://www.siteman.wustl.edu

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

202103025

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.