Gluteal Squeeze for Left Colon Distension

August 18, 2023 updated by: Douglas K. Rex, Indiana University

Gluteal Squeeze for Left Colon Distension During Withdrawal in Colonoscopy

Good distension of the colon during colonoscopy is essential to detect polyps. Gas sometimes escapes the colon through the anus resulting in compromised distension. Pressure on gluteal muscles when the colonoscope tip is in the left colon might help preventing this and thus increase visibility. No previous study looked at this.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Rachel Lahr, BA
  • Phone Number: 3179480724
  • Email: rlahr@iu.edu

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • Spring Mill Medical Center
      • Indianapolis, Indiana, United States, 46202
        • IU Health University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age greater than or equal to 40 years
  2. Scheduled colonoscopy

Exclusion Criteria:

  1. Inflammatory bowel disease
  2. History of colorectal cancer or colon resection
  3. Any colorectal cancer syndromes (FAP, HNPCC, SPS)
  4. Patient with poor bowel preparation identified during insertion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Gluteal squeeze
Patients behind pressed together during part of the colonoscopy (The technicians arms will be covered with a towel to mask the provider of any pressure being applied)
Other: Gluteal squeeze
During procedure, the doctor performing colonoscopy will ask for gluteal pressure. The technician will perform the maneuver, but the doctor will be blinded as the arms of the technician along with the patients behind are covered by a towel.
Sham Comparator: Non-squeeze
When the doctor asks for gluteal pressure, a technician will not administer the pressure but their arms will be covered with a towel and the doctor will not know if the pressure is being administered or not.
Other: No squeeze
During procedure, the doctor performing colonoscopy will ask for gluteal pressure. The technician will not perform the maneuver, but the doctor will be blinded as the arms of the technician along with the patients behind are covered by a towel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left colon distension score
Time Frame: during the procedure
Provider reported distension score in the left colon
during the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left colon withdrawal time
Time Frame: during the procedure
Time taken to withdraw the scope in the left colon
during the procedure
Left colon examination time
Time Frame: during the procedure
Time taken to inspect during left colon withdrawal
during the procedure
Left colon adenoma detection rate
Time Frame: during the procedure
proportion of patients with at least one left colon adenoma
during the procedure
Left colon sessile serrated lesion detection rate
Time Frame: during the procedure
proportion of patients with at least one left colon sessile serrated lesion
during the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Douglas K Rex, MD, Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2022

Primary Completion (Actual)

April 11, 2022

Study Completion (Actual)

April 11, 2022

Study Registration Dates

First Submitted

March 26, 2021

First Submitted That Met QC Criteria

March 30, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

August 22, 2023

Last Update Submitted That Met QC Criteria

August 18, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11109 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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