Prospective RCT Of Water Exchange (WE) vs. WE Plus Cap-Assisted Colonoscopy (NCT03160859) | Clinical Trial Compass
CompletedNot Applicable
Prospective RCT Of Water Exchange (WE) vs. WE Plus Cap-Assisted Colonoscopy
United States280 participantsStarted 2018-06-08
Plain-language summary
This is a study to compare two different, but normally, used methods of colonoscopy in patients undergoing colonoscopy without sedation. There will be two arms in this study: WE (water exchange) control, and WE (water exchange) plus cap (placed at tip of the colonoscope). The patient will prepare himself/herself for the colonoscopy as per normal instructions and he/she will be given the information for the study at that time so that he/she can make a decision to participate in the study. The control method will use water instead of air during insertion of the colonoscope. The study method will use a cap that will fit onto the end of the colonoscope plus water during insertion of the colonoscope. This study will assess if the study method is less painful than the control method.
Who can participate
Age range
50 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Informed/educated (about pros and cons of the unsedated option) Veterans undergoing:
* diagnostic
* surveillance (follow up of polyps)
* screening (first-time) colonoscopy at participating sites
* choosing scheduled unsedated colonoscopy for any reason (lack of escort, personal preference)
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 (except for occult blood or FIT positive in the context of colon cancer screening)
* therapeutic colonoscopy (e.g., hemostasis, removal of large polyp)
* 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 unsedated 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
* active cardiac
* or pulmonary disease
* or other serious disease
* medical condition that would preclude a benefit from colonoscopic screening
* cancer
* or any terminal illness
* prosthetic heart valve
* anticoagulant therapy
* nonmedical problems
* psy…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Real Time Maximum Insertion Pain
Timeframe: Insertion pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour