Clinical Trial: Water Exchange Versus Carbon Dioxide for Colonoscopy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Water Exchange Versus Carbon Dioxide Insufflation to Improve Colonoscopy Screening - a Randomized Controlled Trial

Brief Summary: Colonoscopy is commonly used in screening for colorectal cancer. A refined technique of colonoscopy involving the use of water as the sole modality to aid colonoscope insertion, water exchange, has been described in recent research papers to decrease patient discomfort and pain, and to reduce the need for sedation during colonoscopy when compared with standard air insufflation. Carbon dioxide insufflation has been described to decrease patient discomfort after colonoscopy. No randomized trial has so far compared the use of water exchange to carbon dioxide insufflation. Our hypothesis is that water exchange inflicts less discomfort to patients undergoing colonoscopy than carbon dioxide insufflation. Patients undergoing screening colonoscopy in two centers in Norway, one center in Poland and one center in The Netherlands will be enrolled and randomized to examination of either of the two methods.

Detailed Summary: Single blinded randomized controlled trial.
Sponsor: Sorlandet Hospital HF

Current Primary Outcome: Pain during colonoscopy [ Time Frame: 1 hour ]

Patients will be asked by a blinded assistant immediately after colonoscopy to score pain during the procedure.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pain during colonoscopy [ Time Frame: 30 minutes ]
    Patients will be asked to report pain during colonoscopy to an unblinded study assistant.
  • Cecal intubation rate [ Time Frame: 1 hour ]
    Cecal intubation rate is defined as successful completion of colonoscopy insertion. This will be analyzed on an intention-to-treat basis according to group allocation.
  • Cecal intubation time [ Time Frame: 1 hour ]
    The time taken to complete insertion of the colonoscope.
  • Adenoma detection rate [ Time Frame: 1 hour ]
    Detection of adenomas during each colonoscopy procedure
  • Polyp detection rate [ Time Frame: 1 hour ]
    Detection of any colonic polyp, irrespective of histologic type, during each procedure.
  • Dose of medication [ Time Frame: 1 hour ]
    Dose of sedative and analgesic medication needed to complete the colonoscopy.


Original Secondary Outcome:

  • Pain during colonoscopy [ Time Frame: 30 minutes ]
    Patients will be asked to report pain during colonoscpy to an unblinded study assistant.
  • Cecal intubation rate [ Time Frame: 1 hour ]
    Cecal intubation rate is defined as successfull completion of colonoscopy insertion. This will be analyzed on an intention-to-treat basis according to group allocation.
  • Cecal intubation time [ Time Frame: 1 hour ]
    The time taken to complete insertion of the colonoscope.
  • Adenoma detection rate [ Time Frame: 1 hour ]
    Detection of adenomas during each colonoscopy procedure
  • Polyp detection rate [ Time Frame: 1 hour ]
    Detection of any colonic polyp, irrespective of histologic type, during each procedure.
  • Dose of medication [ Time Frame: 1 hour ]
    Dose of sedative and analgesic medication needed to complete the colonoscopy.


Information By: Sorlandet Hospital HF

Dates:
Date Received: June 29, 2012
Date Started: June 2012
Date Completion:
Last Updated: February 11, 2014
Last Verified: February 2014