Water Exchange (WE) vs. WE Plus Cap-assisted Colonoscopy (VA)

Prospective Randomized Control Trial (RCT) of Water Exchange (WE) vs. WE Plus Cap-assisted Colonoscopy

Water exchange (WE) method has been shown to reduce medication requirement and pain experience during the colonoscopy. Cap-assisted colonoscopy aided by air may also reduced the insertion pain. Therefore, the immediate aim of this study is to assess the generalizability of the impact of WE plus cap (WECAC), as a potentially less painful insertion technique than WE. The control group will use water infusion in lieu of air insufflation during insertion of the colonoscope. The study group will added a cap onto the end of colonoscope during the WE method procedure. This study will also demonstrate if the WECAC method have a shorter insertion time and higher proximal colon adenoma detection rate (ADR) than WE alone in Veterans.

Study Overview

• Status: Active, not recruiting
• Conditions: Colonoscopy; Real-time Maximum Insertion Pain
• Intervention / Treatment: Other: Water; Device: cap

• Study Type: Interventional
• Enrollment (Estimated): 256
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Livermore, California, United States, 94550
      • VA Palo Alto Healthcare System
    • Mather, California, United States, 95655-4200
      • Sacramento VAMC, VA Northern California Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Informed/educated male and female Veterans undergoing screening, diagnostic or surveillance colonoscopy at participating sites, choosing scheduled unsedated colonoscopy for any reason

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
• Therapeutic colonoscopy, 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 unsedation 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
• Medical condition that would preclude a benefit from colonoscopic screening
• Prosthetic heart valve
• Anticoagulant therapy
• Nonmedical problems
• Need for special precautions in performing colonoscopy
• Request of on demand sedation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Water exchange (WE); This group will have the air in the colon removed and replaced with water to guide the insertion of the colonoscope.	Other: Water; Using water instead air to help insertion
Experimental: WE plus cap(WECAC); The procedure of this group is similar with WE group, except a cap will be fitted onto the end of the colonoscope.	Other: Water; Using water instead air to help insertion; Device: cap; A commercially available transparent cap (Olympus) will be fitted to the end of the colonoscope.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Real-time maximum insertion pain(RTMIP) score	Pain during insertion reported to the unblinded assisting nursing, visual analogue scale (VAS): 0=no pain, 10=most severe pain. 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	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion with no insertion pain	Proportion report no pain during insertion time.	2 hours
Insertion time	Time to cecum	2 hours
Proximal colon ADR	ADR from cecum to splenic flexure	2 hours

Collaborators and Investigators

• Sponsor: VA Greater Los Angeles Healthcare System
• Collaborators: VA Palo Alto Health Care System; VA Northern California Health Care System
• Investigators: Principal Investigator: Felix W Leung, MD, VA Greater Los Angeles Healthcare System

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2018
• Primary Completion (Estimated): September 30, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: April 30, 2018
• First Submitted That Met QC Criteria: May 30, 2018
• First Posted (Actual): June 1, 2018

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: pain; colonoscopy; water exchange; cap
• Other Study ID Numbers: VA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes