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

NCT03160859 | Completed Results DMC FDA Device

• 1 other identifier: GAST-015-16S
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Unsedated Colonoscopy; Water Exchange Colonoscopy; Cap; Colonoscopy Pain

Keywords

unsedated colonoscopy; water exchange colonoscopy; cap; colonoscopy pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Proportion of Patients With No Insertion Pain

  Pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour

• Insertion Time

  Insertion time in minutes was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour

• Right Colon Adenoma Detection Rate (ADR)

  Adenoma Detection Rate (ADR) was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour

Study Arms (2)

Control Method

OTHER

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 predominantly during insertion.

Other: Control

Study Method

OTHER

The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a simple commercially available accessory to the colonoscopy device: a cap (Disposable Distal Attachment, Olympus Medical Systems Corp., Tokyo, Japan) fitted to the colonoscope per manufacturer instruction. 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 predominantly during insertion.

Device: Study method

Interventions

Control OTHER

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.

Also known as: Water exchange method

Control Method

Study method DEVICE

Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope.

Also known as: Water exchange method plus cap

Study Method

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• VA Northern California Health Care System: collaborator
• VA Palo Alto Health Care System: collaborator

Study Sites (3)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

VA Northern California Health Care System, Mather, CA

Sacramento, California, 95655, United States

Location

VA Greater Los Angeles Healthcare System, Sepulveda, CA

Sepulveda, California, 91343, United States

Location

Related Publications (26)

• 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.

  PMID: 4682941 BACKGROUND

• 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.

  PMID: 19249764 BACKGROUND

• 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.

  PMID: 21160707 BACKGROUND

• 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.

  PMID: 21686108 BACKGROUND

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

  PMID: 8603544 BACKGROUND

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

  PMID: 9649011 BACKGROUND

• 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.

  PMID: 10228251 BACKGROUND

• 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.

  PMID: 15942439 BACKGROUND

• 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.

  PMID: 10406249 BACKGROUND

• 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.

  PMID: 21686115 BACKGROUND

• 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.

  PMID: 17608779 BACKGROUND

• 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.

  PMID: 18274901 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 11474385 BACKGROUND

• 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.

  PMID: 20619405 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 24890443 BACKGROUND

• 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.

  PMID: 24218307 BACKGROUND

• 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.

  PMID: 25262100 BACKGROUND

• 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.

  PMID: 25956838 BACKGROUND

• 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.

  PMID: 27744665 BACKGROUND

• 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.

  PMID: 23235654 BACKGROUND

• 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.

  PMID: 23884794 BACKGROUND

• 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.

  PMID: 33725848 BACKGROUND

• 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.

  PMID: 11051348 BACKGROUND

• Leung FW, Cheung R, Friedland S, Jacob N, Leung JW, Pan JY, Quan SY, Sul J, Yen AW, Jamgotchian N, Chen Y, Dixit V, Shaikh A, Elashoff D, Saha A, Wilhalme H. Prospective randomized controlled trial of water exchange plus cap versus water exchange colonoscopy in unsedated veterans. Gastrointest Endosc. 2025 Feb;101(2):402-413.e2. doi: 10.1016/j.gie.2024.07.010. Epub 2024 Jul 23.

  PMID: 39053653 DERIVED

MeSH Terms

Conditions

Anterior polar cataract 2

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Limitations and Caveats

The limitations included: (1) subjects were mostly male Veterans, (2) colonoscopists were unblinded, (3) colonoscopist-assessed patient anxiety was subjective and not measured on a standardized anxiety scale.

Results Point of Contact

• Title: Felix W. Leung, M.D, Staff Gastroenterologist
• Organization: Veterans Administration Greater Los Angeles Healthcare System

felix.leung@va.gov

818-891-7711

Study Officials

• Felix W. Leung, MD

  VA Greater Los Angeles Healthcare System, Sepulveda, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This will be a multi-VA site, prospective RCT to compare different methods with 2 arms to determine which is less painful: water alone or water plus cap. Randomization will be based on computer generated random numbers placed inside opaque sealed envelopes. The envelope will be opened to reveal the code when the colonoscopist is ready to insert the endoscope to begin the examination. 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. Control Method: Involves unsedated colonoscopy with water exchange. Residual air 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: Involves unsedated colonoscopy with water exchange and the addition of a commercially available accessory fitted onto the colonoscope.

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: May 19, 2017
• Study Start: June 8, 2018
• Primary Completion: October 28, 2022
• Study Completion: October 28, 2022
• Last Updated: December 12, 2023
• Results First Posted: December 12, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)