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

Not Applicable

Active, not recruiting

• Conditions: Colonoscopy; Real-time Maximum Insertion Pain
• Interventions: Device: cap; Other: Water

• Registration Number: NCT03543124
• Lead Sponsor: VA Greater Los Angeles Healthcare System

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-30
• Study Start: 2018-05-21
• Study First Submitted QC: 2018-05-30
• Study First Posted: 2018-06-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-28
• Last Update Posted: 2023-08-01
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 256

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WE plus cap(WECAC)	Water	The procedure of this group is similar with WE group, except a cap will be fitted onto the end of the colonoscope.
Water exchange (WE)	Water	This group will have the air in the colon removed and replaced with water to guide the insertion of the colonoscope.
WE plus cap(WECAC)	cap	The procedure of this group is similar with WE group, except a cap will be fitted onto the end of the colonoscope.

Primary Outcome Measures

Name	Time	Method
Real-time maximum insertion pain(RTMIP) score	2 hours	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

Secondary Outcome Measures

Name	Time	Method
Insertion time	2 hours	Time to cecum
Proximal colon ADR	2 hours	ADR from cecum to splenic flexure
Proportion with no insertion pain	2 hours	Proportion report no pain during insertion time.

Trial Locations

Locations (2)

VA Palo Alto Healthcare System; 🇺🇸 Livermore, California, United States

Sacramento VAMC, VA Northern California Healthcare System; 🇺🇸 Mather, California, United States