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Gluteal Squeeze for Left Colon Distension

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ClinicalTrials.gov Identifier: NCT04827485
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : January 20, 2022
Sponsor:
Information provided by (Responsible Party):
Douglas K. Rex, Indiana University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Other: Gluteal squeeze Other: No squeeze Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Gluteal Squeeze for Left Colon Distension During Withdrawal in Colonoscopy
Actual Study Start Date : January 13, 2022
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Left colon distension score [ Time Frame: during the procedure ]
    Provider reported distension score in the left colon


Secondary Outcome Measures :
  1. Left colon withdrawal time [ Time Frame: during the procedure ]
    Time taken to withdraw the scope in the left colon

  2. Left colon examination time [ Time Frame: during the procedure ]
    Time taken to inspect during left colon withdrawal

  3. Left colon adenoma detection rate [ Time Frame: during the procedure ]
    proportion of patients with at least one left colon adenoma

  4. Left colon sessile serrated lesion detection rate [ Time Frame: during the procedure ]
    proportion of patients with at least one left colon sessile serrated lesion


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04827485


Contacts
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Contact: Rachel Lahr, BA 3179480724 rlahr@iu.edu

Locations
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United States, Indiana
IU Health University Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Rachel E Lahr    317-948-0724    rlahr@iu.edu   
Spring Mill Medical Center Recruiting
Indianapolis, Indiana, United States, 46290
Contact: Rachel E Lahr    317-948-0724    rlahr@iu.edu   
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Douglas K Rex, MD Indiana University
More Information
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Publications:

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Responsible Party: Douglas K. Rex, Professor Emeritus, Indiana University
ClinicalTrials.gov Identifier: NCT04827485    
Other Study ID Numbers: 11109
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: January 20, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases