Clinical trial NCT04827485: Gluteal Squeeze for Left Colon Distension
Official title: Gluteal Squeeze for Left Colon Distension During Withdrawal in Colonoscopy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colorectal Neoplasms
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 89
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility 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

Primary outcomes:
measure: Left colon distension score
timeFrame: during the procedure
Secondary outcomes:
measure: Left colon withdrawal time
timeFrame: during the procedure
measure: Left colon examination time
timeFrame: during the procedure
measure: Left colon adenoma detection rate
timeFrame: during the procedure
measure: Left colon sessile serrated lesion detection rate
timeFrame: during the procedure
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Health University Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Spring Mill Medical Center
state: Indiana
Study officials:
affiliation: Indiana University
name: Douglas K Rex, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.