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

VA Greater Los Angeles Healthcare System

Status: Active, not recruiting

Conditions: Real-time Maximum Insertion Pain; Colonoscopy

Treatments: Device: cap; Other: Water

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03543124

VA

Details and patient eligibility

About

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.

Enrollment: 256 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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256 participants in 2 patient groups

Water exchange (WE)

Active Comparator group

Description:

This group will have the air in the colon removed and replaced with water to guide the insertion of the colonoscope.

Treatment:

Other: Water

WE plus cap(WECAC)

Experimental group

Description:

The procedure of this group is similar with WE group, except a cap will be fitted onto the end of the colonoscope.

Treatment:

Device: cap

Other: Water