Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
89 participants
INTERVENTIONAL
2022-01-13
2022-04-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
QUADRUPLE
Study Groups
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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)
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
2. Scheduled colonoscopy
Exclusion Criteria
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
40 Years
ALL
Yes
Sponsors
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Indiana University
OTHER
Responsible Party
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Douglas K. Rex
Professor Emeritus
Principal Investigators
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Douglas K Rex, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Locations
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IU Health University Hospital
Indianapolis, Indiana, United States
Spring Mill Medical Center
Indianapolis, Indiana, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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11109
Identifier Type: -
Identifier Source: org_study_id
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