Prospective RCT Of Water Exchange (WE) vs. WE Plus Cap-Assisted Colonoscopy

Water Exchange Colonoscopy Clinical Trial

Official title:

Prospective RCT of Water Exchange (WE) vs. WE Plus Cap-Assisted Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03160859
• Other study ID #: GAST-015-16S
• Status: Completed
• Phase: N/A
• Start date: June 8, 2018
• Est. completion date: October 28, 2022

Study information

• Verified date: November 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a study to compare two different, but normally, used methods of colonoscopy in patients undergoing colonoscopy without sedation. There will be two arms in this study: WE (water exchange) control, and WE (water exchange) plus cap (placed at tip of the colonoscope). The patient will prepare himself/herself for the colonoscopy as per normal instructions and he/she will be given the information for the study at that time so that he/she can make a decision to participate in the study. The control method will use water instead of air during insertion of the colonoscope. The study method will use a cap that will fit onto the end of the colonoscope plus water during insertion of the colonoscope. This study will assess if the study method is less painful than the control method.

Description:

This will be a multi-VA site, unblinded investigators, prospective randomized control trial (RCT). Randomization (WE, WE + cap) will be based on computer generated random numbers placed inside opaque sealed envelopes. The envelope (in pre-arranged order set up by statistics consultant) will be opened to reveal the code when the colonoscopist is ready to insert the endoscope to begin the examination. This will be a comparison of two arms (WE, WE + cap) to see which one is less painful.

Patients who are willing to participate will sign an informed consent before starting the colonoscopy procedure. Separate parallel randomization will be set up at each site, stratified type of colonoscopy (screening, surveillance, diagnostic). All subjects will have scheduled unsedated colonoscopy as a result of lack of escort or personal preference for no sedation. Randomization will be set up by statistics consultant.

Control Method: One arm of the study will include unsedated colonoscopy with water exchange (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual fecal debris, predominantly during insertion.

Study method: The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a cap, fitted to the colonoscope per manufacturer instruction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: October 28, 2022
• Est. primary completion date: October 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Informed/educated (about pros and cons of the unsedated option) Veterans undergoing:

• diagnostic

• surveillance (follow up of polyps)

• screening (first-time) colonoscopy at participating sites

• choosing scheduled unsedated colonoscopy for any reason (lack of escort, personal preference)

Exclusion Criteria:

• decline to be randomized

• unable to give consent or respond to questionnaires

• history of colon surgery

• active inflammatory bowel disease

• lower gastrointestinal bleeding (except for occult blood or FIT positive in the context of colon cancer screening)

• therapeutic colonoscopy (e.g., hemostasis, removal of large polyp)

• proctosigmoidoscopy

• bidirectional endoscopy

• inadequate consumption of bowel preparation

• known history of severe diverticulosis or diverticulitis

• history of abdominal surgery previously requiring sedation for colonoscopy

• current narcotic/anxiolytic medication use

• prior unsuccessful experience with unsedated colonoscopy

• emergent colonoscopy

• evidence of colonic obstruction based on pre-colonoscopy clinical evaluation

• current participation in other studies

• medical condition that could increase the risk associated with colonoscopy

• active cardiac

• or pulmonary disease

• or other serious disease

• medical condition that would preclude a benefit from colonoscopic screening

• cancer

• or any terminal illness

• prosthetic heart valve

• anticoagulant therapy

• nonmedical problems

• psychiatric disorders

• excessive use of alcohol

• need for special precautions in performing colonoscopy

• antibiotic prophylaxis

• request of on demand sedation

Related Conditions & MeSH terms

• Cap
• Colonoscopy Pain
• Unsedated Colonoscopy
• Water Exchange Colonoscopy

Intervention

Other:
• Control
Unsedated colonoscopy with water exchange (WE) where the residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water is removed predominantly during insertion.

Device:
• Study method
Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope.

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System, Palo Alto, CA	Palo Alto	California
United States	VA Northern California Health Care System, Mather, CA	Sacramento	California
United States	VA Greater Los Angeles Healthcare System, Sepulveda, CA	Sepulveda	California

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	VA Northern California Health Care System, VA Palo Alto Health Care System

Country where clinical trial is conducted

United States, 

References & Publications (25)

Anderson JC, Gonzalez JD, Messina CR, Pollack BJ. Factors that predict incomplete colonoscopy: thinner is not always better. Am J Gastroenterol. 2000 Oct;95(10):2784-7. doi: 10.1111/j.1572-0241.2000.03186.x. — View Citation

Cadoni S, Falt P, Gallittu P, Liggi M, Mura D, Smajstrla V, Erriu M, Leung FW. Water Exchange Is the Least Painful Colonoscope Insertion Technique and Increases Completion of Unsedated Colonoscopy. Clin Gastroenterol Hepatol. 2015 Nov;13(11):1972-80.e1-3. doi: 10.1016/j.cgh.2015.04.178. Epub 2015 May 5. — View Citation

Cadoni S, Gallittu P, Sanna S, Fanari V, Porcedda ML, Erriu M, Leung FW. A two-center randomized controlled trial of water-aided colonoscopy versus air insufflation colonoscopy. Endoscopy. 2014 Mar;46(3):212-8. doi: 10.1055/s-0033-1353604. Epub 2013 Nov 11. — View Citation

Cadoni S, Sanna S, Gallittu P, Argiolas M, Fanari V, Porcedda ML, Erriu M, Leung FW. A randomized, controlled trial comparing real-time insertion pain during colonoscopy confirmed water exchange to be superior to water immersion in enhancing patient comfort. Gastrointest Endosc. 2015 Mar;81(3):557-66. doi: 10.1016/j.gie.2014.07.029. Epub 2014 Sep 26. Erratum In: Gastrointest Endosc. 2015 May;81(5):1303. — View Citation

Cataldo PA. Colonoscopy without sedation. Dis Colon Rectum. 1996 Mar;39(3):257-61. doi: 10.1007/BF02049463. — View Citation

Early DS, Saifuddin T, Johnson JC, King PD, Marshall JB. Patient attitudes toward undergoing colonoscopy without sedation. Am J Gastroenterol. 1999 Jul;94(7):1862-5. doi: 10.1111/j.1572-0241.1999.01219.x. — View Citation

Felix W. Leung, Hartley Cohen, Stanley K. Dea, Dennis M. Jensen, Thomas O. Kovacs, Gordon V. Ohning, Joseph R. Pisegna, Alireza Sedarat, Alan Sheinbaum, Timothy C. Simmons, Rebecca Slomovic, Brennan M. Spiegel, Mitchell J. Spirt, James Sul and Rabindra R. Watson. Scheduled unsedated colonoscopy - a novel tool for managing no shows due to lack of escorts required for conscious sedation. Gastrointestinal Endoscopy, 2014-05-01, Volume 79, Issue 5, Pages AB178-AB179

Hoffman MS, Butler TW, Shaver T. Colonoscopy without sedation. J Clin Gastroenterol. 1998 Jun;26(4):279-82. doi: 10.1097/00004836-199806000-00013. — View Citation

Holme O, Bretthauer M, de Lange T, Seip B, Huppertz-Hauss G, Hoie O, Sandvei P, Ystrom CM, Hoff G. Risk stratification to predict pain during unsedated colonoscopy: results of a multicenter cohort study. Endoscopy. 2013 Sep;45(9):691-6. doi: 10.1055/s-0033-1344239. Epub 2013 Jul 24. — View Citation

Hsieh YH, Koo M, Leung FW. A patient-blinded randomized, controlled trial comparing air insufflation, water immersion, and water exchange during minimally sedated colonoscopy. Am J Gastroenterol. 2014 Sep;109(9):1390-400. doi: 10.1038/ajg.2014.126. Epub 2014 Jun 3. — View Citation

Jonas DE, Russell LB, Sandler RS, Chou J, Pignone M. Patient time requirements for screening colonoscopy. Am J Gastroenterol. 2007 Nov;102(11):2401-10. doi: 10.1111/j.1572-0241.2007.01387.x. Epub 2007 Jun 29. — View Citation

Kim HG. Painless Colonoscopy: Available Techniques and Instruments. Clin Endosc. 2016 Sep;49(5):444-448. doi: 10.5946/ce.2016.132. Epub 2016 Sep 30. — View Citation

Leung FW, Aljebreen AM, Brocchi E, Chang EB, Liao WC, Mizukami T, Schapiro M, Triantafyllou K. Sedation-risk-free colonoscopy for minimizing the burden of colorectal cancer screening. World J Gastrointest Endosc. 2010 Mar 16;2(3):81-9. doi: 10.4253/wjge.v2.i3.81. — View Citation

Leung FW, Harker JO, Jackson G, Okamoto KE, Behbahani OM, Jamgotchian NJ, Aharonian HS, Guth PH, Mann SK, Leung JW. A proof-of-principle, prospective, randomized, controlled trial demonstrating improved outcomes in scheduled unsedated colonoscopy by the water method. Gastrointest Endosc. 2010 Oct;72(4):693-700. doi: 10.1016/j.gie.2010.05.020. Epub 2010 Jul 8. — View Citation

Leung FW. Is there a place for sedationless colonoscopy? J Interv Gastroenterol. 2011 Jan;1(1):19-22. doi: 10.4161/jig.1.1.14592. — View Citation

Leung FW. Patients' perspective - written testimonials from physician-patients and oral accounts presented by patients in person. J Interv Gastroenterol. 2011 Jan;1(1):45-46. doi: 10.4161/jig.1.1.14605. No abstract available. — View Citation

Leung FW. The case of unsedated screening colonoscopy in the United States. Gastrointest Endosc. 2009 Jun;69(7):1354-6. doi: 10.1016/j.gie.2008.12.234. Epub 2009 Feb 27. No abstract available. — View Citation

Leung FW. Unsedated colonoscopy introduced to ensure access is acceptable to a subgroup of veterans. Dig Dis Sci. 2008 Oct;53(10):2719-22. doi: 10.1007/s10620-007-0192-8. Epub 2008 Feb 15. — View Citation

Leung JW, Mann SK, Siao-Salera R, Canete W, Leung FW. The established and time-tested water exchange method in scheduled unsedated colonoscopy significantly enhanced patient-centered outcomes without prolonging procedural times - A RCT. J Interv Gastroenterol. 2013;3(1):7-11.

Morgan J, Thomas K, Lee-Robichaud H, Nelson RL, Braungart S. Transparent cap colonoscopy versus standard colonoscopy to improve caecal intubation. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD008211. doi: 10.1002/14651858.CD008211.pub3. — View Citation

Rex DK, Imperiale TF, Portish V. Patients willing to try colonoscopy without sedation: associated clinical factors and results of a randomized controlled trial. Gastrointest Endosc. 1999 May;49(5):554-9. doi: 10.1016/s0016-5107(99)70381-0. — View Citation

Subramanian S, Liangpunsakul S, Rex DK. Preprocedure patient values regarding sedation for colonoscopy. J Clin Gastroenterol. 2005 Jul;39(6):516-9. doi: 10.1097/01.mcg.0000165667.79530.44. — View Citation

Terruzzi V, Meucci G, Radaelli F, Terreni N, Minoli G. Routine versus "on demand" sedation and analgesia for colonoscopy: a prospective randomized controlled trial. Gastrointest Endosc. 2001 Aug;54(2):169-74. doi: 10.1067/mge.2001.113923. — View Citation

Wang L, Jia H, Luo H, Kang X, Zhang L, Wang X, Yao S, Tao Q, Pan Y, Guo X. A novel intubation discomfort score to predict painful unsedated colonoscopy. Medicine (Baltimore). 2021 Mar 12;100(10):e24907. doi: 10.1097/MD.0000000000024907. — View Citation

Wolff WI, Shinya H. Polypectomy via the fiberoptic colonoscope. Removal of neoplasms beyond reach of the sigmoidoscope. N Engl J Med. 1973 Feb 15;288(7):329-32. doi: 10.1056/NEJM197302152880701. No abstract available. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Real Time Maximum Insertion Pain	Pain during insertion reported to the unblinded assisting nurse, visual analogue scale, VAS: 0=none, 10=most severe. The highest pain score will be tabulated for analysis. Timing of data collection will be at the discretion of the nurse to minimize bias by colonoscopist behavior.	Insertion pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour
Secondary	Proportion of Patients With No Insertion Pain	Proportion of patients who report no pain during insertion of the colonoscope.	Pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour
Secondary	Insertion Time	Time to cecum (clock display on monitor), faster insertion is a quality marker	Insertion time in minutes was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour
Secondary	Right Colon Adenoma Detection Rate (ADR)	Right colon Adenoma Detection Rate (ADR) is the proportion of patients with at least one adenoma in the part of the colon between the cecum and the hepatic flexure.	Adenoma Detection Rate (ADR) was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour