Comparing Water Exchange, Water Immersion and Air Insufflation Methods During Colonoscopy With the Option of on Demand Sedation
Condition: Colon Neoplasm
MeSH terms: Colonic Neoplasms
Study type: Interventional

Summary: 
      This prospective, randomized controlled trial compares traditional air insufflation with
      water immersion and water exchange in patients undergoing colonoscopy using on demand
      sedation. We test the hypothesis that compared with air insufflation the proportion of
      patients who require on demand sedation during colonoscopy will be significantly lowered by
      water immersion and water exchange, and water exchange will produce the greatest reduction
    

Detailed description: 
      The patients will be allocated into 3 groups by computerized randomization. In group A (water
      exchange), water will be infused and removed at the same time throughout the entire colon
      during the insertion phase with the air pump turned off. In group B (water immersion), water
      will be infused in the insertion phase and removed in the withdrawal phase. The water will be
      used mainly to open the lumen, without attempting to clear the colon contents. In group A and
      B, warm-to-touch water will be infused mainly infused through the accessory channel of the
      colonoscope using a foot-switch controlled water pump (JW2, Fujinon, Saitama, Japan). Air
      insufflation not used until the cecum has been reached. . In group C, air insufflation will
      be used throughout the procedure. Aliquots of 30 to 50 ml of water will be used for washing
      residual stool, as needed. In all three groups, loop reduction maneuvers, abdominal
      compression and change of patient position will be utilized at the discretion of the
      colonoscopist and recorded. Intubation of the cecum will be defined as successful only if the
      base of the cecum is touched with the tip of the colonoscope. Detailed examinations will be
      undertaken during the withdrawal phase.

      During colonoscopy, a study nurse will ask the patient to report the level of pain (0 = none,
      10 = most severe) at 2 to 3-minute intervals or at any time the patient voiced discomfort.
      For pain scores ≧2, maneuvers to minimize pain will be implemented. Immediately thereafter,
      the nurse will offer sedation, which the patients can accept or decline. If accepted, after
      an initial bolus of 1 mg/kg or 0.5 mg/kg for patients over 65 years propofol (Diprivan,
      Astra-Zeneca, Stockholm, Sweden) will be titrated in 20- to 30-mg increments to achieve an
      adequate level of sedation. The need of additional drug will be estimated by patient pain
      response (moans, grimaces and movements). Usually no more propofol will be added during the
      withdrawal phase. The initial amount of propofol, and those before and after arrival to the
      cecum will be recorded.

      The following parameters will be evaluated and recorded on the patient data sheet: quality of
      bowel preparation, cecal intubation time, withdrawal time total procedure time, use of
      abdominal pressure, need for changing position, presence of polyps and reasons for incomplete
      colonoscopy.

      The procedure will be recorded and stored as digital files.
    

Intervention name(s): water immersion; water exchange; air insufflation
Intervention type(s): Procedure; Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: colonoscopy; pain; sedation; water