NCT03160859

Prospective RCT Of Water Exchange (WE) vs. WE Plus Cap-Assisted Colonoscopy

Prospective RCT of Water Exchange (WE) vs. WE Plus Cap-Assisted Colonoscopy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed description

This will be a multi-VA site, unblinded investigators, prospective randomized control trial (RCT). Randomization (WE, WE + cap) will be based on computer generated random numbers placed inside opaque sealed envelopes. The envelope (in pre-arranged order set up by statistics consultant) will be opened to reveal the code when the colonoscopist is ready to insert the endoscope to begin the examination. This will be a comparison of two arms (WE, WE + cap) to see which one is less painful. Patients who are willing to participate will sign an informed consent before starting the colonoscopy procedure. Separate parallel randomization will be set up at each site, stratified type of colonoscopy (screening, surveillance, diagnostic). All subjects will have scheduled unsedated colonoscopy as a result of lack of escort or personal preference for no sedation. Randomization will be set up by statistics consultant. Control Method: One arm of the study will include unsedated colonoscopy with water exchange (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual fecal debris, predominantly during insertion. Study method: The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a cap, fitted to the colonoscope per manufacturer instruction.

Conditions

• Unsedated Colonoscopy
• Water Exchange Colonoscopy
• Cap
• Colonoscopy Pain

Interventions

Type	Name	Description
OTHER	Control	Unsedated colonoscopy with water exchange (WE) where the residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water is removed predominantly during insertion.
DEVICE	Study method	Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope.

Timeline

• Start date: 2018-06-08
• Primary completion: 2022-10-28
• Completion: 2022-10-28
• First posted: 2017-05-19
• Last updated: 2023-12-12
• Results posted: 2023-12-12

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study