Study Stopped
PI decision.
Gluteal Squeeze for Left Colon Distension
1 other identifier
interventional
89
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2022
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2021
CompletedFirst Posted
Study publicly available on registry
April 1, 2021
CompletedStudy Start
First participant enrolled
January 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 11, 2022
CompletedAugust 22, 2023
August 1, 2023
3 months
March 26, 2021
August 18, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Left colon distension score
Provider reported distension score in the left colon
during the procedure
Secondary Outcomes (4)
Left colon withdrawal time
during the procedure
Left colon examination time
during the procedure
Left colon adenoma detection rate
during the procedure
Left colon sessile serrated lesion detection rate
during the procedure
Study Arms (2)
Gluteal squeeze
ACTIVE COMPARATORPatients 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)
Non-squeeze
SHAM COMPARATORWhen 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Age greater than or equal to 40 years
- Scheduled colonoscopy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
IU Health University Hospital
Indianapolis, Indiana, 46202, United States
Spring Mill Medical Center
Indianapolis, Indiana, 46290, United States
Related Publications (6)
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.
PMID: 28428142BACKGROUNDCorley 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.
PMID: 24693890BACKGROUNDRex 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.
PMID: 25448873BACKGROUNDRex 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.
PMID: 10625792BACKGROUNDWoltjen 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.
PMID: 15672054BACKGROUNDDuloy 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.
PMID: 29908363BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Douglas K Rex, MD
Indiana University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Emeritus
Study Record Dates
First Submitted
March 26, 2021
First Posted
April 1, 2021
Study Start
January 13, 2022
Primary Completion
April 11, 2022
Study Completion
April 11, 2022
Last Updated
August 22, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share