Clinical Trial: Colonoscopy Screening Using a Novel Slim Colonoscope - a Randomized Controlled Trial

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

Official Title: Colonoscopy Screening Using a Novel Slim Colonoscope - a Randomized Controlled Trial

Brief Summary: The purpose of this study is to compare the performance of a new prototype colonoscope with a standard colonoscope used world-wide today. The prototype colonoscope is more flaccid with a smaller diameter than the standard colonoscope. The hypothesis to be tested is that the prototype will improve negotiation of sharp bends and inflict less discomfort or pain to the patient. Both colonoscopes are manufactured by the same company.

Detailed Summary:
Sponsor: Sorlandet Hospital HF

Current Primary Outcome: Patients´ evaluation of pain and discomfort [ Time Frame: 24 hours ]

Analysis of validated feed-back questionnaires to be filled in on the day after the proceudre by the trial participants.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time used to reach the caecum [ Time Frame: 1 hour ]
    The time used to reach the caecum will be recorded with a stop watch during the procedure.
  • Need for sedation/analgesics during the colonoscopy procedure [ Time Frame: 1 hour ]
    If sedation/analgesics is administered during the colonoscopy procedure, the name of the agent, dose and route of administration will be recorded immediately.
  • Need to change to a different colonoscope to complete the procedure [ Time Frame: 10 minutes ]
    If the colonoscopist decides to change to a different colonoscope during the procedure, the reason is recorded immediately after the procedure. The number of procedures where there is a change of colonoscope will be recorded.
  • Caecum intubation rate [ Time Frame: 30 minutes ]
    The colonic segment reached during each colonoscopy is recorded immediately following the procedure. Caecal intubation rate describes the number of complete colonoscopies.


Original Secondary Outcome: Same as current

Information By: Sorlandet Hospital HF

Dates:
Date Received: March 21, 2011
Date Started: March 2011
Date Completion:
Last Updated: April 26, 2012
Last Verified: April 2012