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

Colonoscopy Clinical Trial

— VA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03543124
• Other study ID #: VA
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 21, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: VA Greater Los Angeles Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 256
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonoscopy
• Real-time Maximum Insertion Pain

Intervention

Device:
• cap
A commercially available transparent cap (Olympus) will be fitted to the end of the colonoscope.

Other:
• Water
Using water instead air to help insertion

Locations

Country	Name	City	State
United States	VA Palo Alto Healthcare System	Livermore	California
United States	Sacramento VAMC, VA Northern California Healthcare System	Mather	California

Sponsors (3)

Lead Sponsor	Collaborator
VA Greater Los Angeles Healthcare System	VA Northern California Health Care System, VA Palo Alto Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion with no insertion pain	Proportion report no pain during insertion time.	2 hours
Secondary	Insertion time	Time to cecum	2 hours
Secondary	Proximal colon ADR	ADR from cecum to splenic flexure	2 hours