Prospective RCT Of Water Exchange (WE) vs. WE Plus Cap-Assisted Colonoscopy
Condition: Unsedated Colonoscopy; Water Exchange Colonoscopy; Cap; Colonoscopy Pain
Study type: Interventional

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.
    

Intervention name(s): Control; Study method
Intervention type(s): Other; Device
Intervention description(s): 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.; Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope.
Other intervention name(s): Water exchange method; Water exchange method plus cap
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This will be a multi-VA site, prospective RCT to compare different methods with 2 arms to determine which is less painful: water alone or water plus cap. Randomization will be based on computer generated random numbers placed inside opaque sealed envelopes. The envelope will be opened to reveal the code when the colonoscopist is ready to insert the endoscope to begin the examination. 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. Control Method: Involves unsedated colonoscopy with water exchange. Residual air 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: Involves unsedated colonoscopy with water exchange and the addition of a commercially available accessory fitted onto the colonoscope.
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: unsedated colonoscopy; water exchange colonoscopy; cap; colonoscopy pain