Gluteal Squeeze for Left Colon Distension

Colorectal Neoplasms Clinical Trial

Official title:

Gluteal Squeeze for Left Colon Distension During Withdrawal in Colonoscopy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04827485
• Other study ID #: 11109
• Status: Terminated
• Phase: N/A
• Start date: January 13, 2022
• Est. completion date: April 11, 2022

Study information

• Verified date: August 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 89
• Est. completion date: April 11, 2022
• Est. primary completion date: April 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	IU Health University Hospital	Indianapolis	Indiana
United States	Spring Mill Medical Center	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left colon distension score	Provider reported distension score in the left colon	during the procedure
Secondary	Left colon withdrawal time	Time taken to withdraw the scope in the left colon	during the procedure
Secondary	Left colon examination time	Time taken to inspect during left colon withdrawal	during the procedure
Secondary	Left colon adenoma detection rate	proportion of patients with at least one left colon adenoma	during the procedure
Secondary	Left colon sessile serrated lesion detection rate	proportion of patients with at least one left colon sessile serrated lesion	during the procedure