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Gluteal Squeeze for Left Colon Distension

Primary Purpose

Colorectal Neoplasms

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gluteal squeeze
No squeeze
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Neoplasms

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • IU Health University Hospital
  • Spring Mill Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Gluteal squeeze

Non-squeeze

Arm Description

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)

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.

Outcomes

Primary Outcome Measures

Left colon distension score
Provider reported distension score in the left colon

Secondary Outcome Measures

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

Full Information

First Posted
March 26, 2021
Last Updated
August 18, 2023
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT04827485
Brief Title
Gluteal Squeeze for Left Colon Distension
Official Title
Gluteal Squeeze for Left Colon Distension During Withdrawal in Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
PI decision.
Study Start Date
January 13, 2022 (Actual)
Primary Completion Date
April 11, 2022 (Actual)
Study Completion Date
April 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gluteal squeeze
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Non-squeeze
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Gluteal squeeze
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No squeeze
Intervention Description
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.
Primary Outcome Measure Information:
Title
Left colon distension score
Description
Provider reported distension score in the left colon
Time Frame
during the procedure
Secondary Outcome Measure Information:
Title
Left colon withdrawal time
Description
Time taken to withdraw the scope in the left colon
Time Frame
during the procedure
Title
Left colon examination time
Description
Time taken to inspect during left colon withdrawal
Time Frame
during the procedure
Title
Left colon adenoma detection rate
Description
proportion of patients with at least one left colon adenoma
Time Frame
during the procedure
Title
Left colon sessile serrated lesion detection rate
Description
proportion of patients with at least one left colon sessile serrated lesion
Time Frame
during the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age greater than or equal to 40 years Scheduled colonoscopy Exclusion Criteria: Inflammatory bowel disease History of colorectal cancer or colon resection Any colorectal cancer syndromes (FAP, HNPCC, SPS) Patient with poor bowel preparation identified during insertion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas K Rex, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
IU Health University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Spring Mill Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28428142
Citation
Kaminski MF, Wieszczy P, Rupinski M, Wojciechowska U, Didkowska J, Kraszewska E, Kobiela J, Franczyk R, Rupinska M, Kocot B, Chaber-Ciopinska A, Pachlewski J, Polkowski M, Regula J. Increased Rate of Adenoma Detection Associates With Reduced Risk of Colorectal Cancer and Death. Gastroenterology. 2017 Jul;153(1):98-105. doi: 10.1053/j.gastro.2017.04.006. Epub 2017 Apr 17.
Results Reference
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PubMed Identifier
24693890
Citation
Corley DA, Jensen CD, Marks AR, Zhao WK, Lee JK, Doubeni CA, Zauber AG, de Boer J, Fireman BH, Schottinger JE, Quinn VP, Ghai NR, Levin TR, Quesenberry CP. Adenoma detection rate and risk of colorectal cancer and death. N Engl J Med. 2014 Apr 3;370(14):1298-306. doi: 10.1056/NEJMoa1309086.
Results Reference
background
PubMed Identifier
25448873
Citation
Rex DK, Schoenfeld PS, Cohen J, Pike IM, Adler DG, Fennerty MB, Lieb JG 2nd, Park WG, Rizk MK, Sawhney MS, Shaheen NJ, Wani S, Weinberg DS. Quality indicators for colonoscopy. Am J Gastroenterol. 2015 Jan;110(1):72-90. doi: 10.1038/ajg.2014.385. Epub 2014 Dec 2. No abstract available.
Results Reference
background
PubMed Identifier
10625792
Citation
Rex DK. Colonoscopic withdrawal technique is associated with adenoma miss rates. Gastrointest Endosc. 2000 Jan;51(1):33-6. doi: 10.1016/s0016-5107(00)70383-x.
Results Reference
background
PubMed Identifier
15672054
Citation
Woltjen JA. A retrospective analysis of cecal barotrauma caused by colonoscope air flow and pressure. Gastrointest Endosc. 2005 Jan;61(1):37-45. doi: 10.1016/s0016-5107(04)02453-8.
Results Reference
background
PubMed Identifier
29908363
Citation
Duloy A, Yadlapati RH, Benson M, Gawron AJ, Kahi CJ, Kaltenbach TR, McClure J, Gregory DL, Keswani RN. Video-Based Assessments of Colonoscopy Inspection Quality Correlate With Quality Metrics and Highlight Areas for Improvement. Clin Gastroenterol Hepatol. 2019 Mar;17(4):691-700. doi: 10.1016/j.cgh.2018.05.060. Epub 2018 Jun 14.
Results Reference
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Gluteal Squeeze for Left Colon Distension

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