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

NCT05018325 | Terminated DMC

• 1 other identifier: 202103025
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer; Rectal Cancer; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Miss rate of advanced adenomas

  Time of colonoscopy (day 1)

Study Arms (3)

Arm 1: Colonoscopy 6 minute withdrawal time

ACTIVE COMPARATOR

-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

Arm 2: Colonoscopy 9 minute withdrawal time

EXPERIMENTAL

-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

Arm 3: Colonoscopy 12 minute withdrawal time

EXPERIMENTAL

-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

Interventions

Colonoscopy with 6 minute withdrawal PROCEDURE

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

Arm 1: Colonoscopy 6 minute withdrawal time

Colonoscopy 9 minute withdrawal PROCEDURE

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

Arm 2: Colonoscopy 9 minute withdrawal time

Colonoscopy 12 minute withdrawal PROCEDURE

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

Arm 3: Colonoscopy 12 minute withdrawal time

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms; Colorectal Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Vladimir Kushnir, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 24, 2021
• Study Start: August 30, 2021
• Primary Completion: August 19, 2022
• Study Completion: August 19, 2022
• Last Updated: August 31, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication without an end date
• Access Criteria: Anyone who wishes to access the data.

Locations

US (1)