Water Exchange (WE) vs. WE Plus Cap-assisted Colonoscopy
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 6/3/2018 |
| Start Date: | May 21, 2018 |
| End Date: | December 31, 2022 |
| Contact: | Nora Jamgotchian, MS |
| Email: | Nora.Jamgotchian@va.gov |
| Phone: | 818-895-9426 |
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.
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.
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
We found this trial at
2
sites
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10535 Hospital Way
Mather, California 95655
Mather, California 95655
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