NCT01370928
Completed
Phase 3
Colonoscopy Screening Using a Novel Slim Colonoscope - a Randomized Controlled Trial
Sorlandet Hospital HF1 site in 1 country190 target enrollmentMarch 2011
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Sorlandet Hospital HF
- Enrollment
- 190
- Locations
- 1
- Primary Endpoint
- Patients´ evaluation of pain and discomfort
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Persons included in the NordICC trial are eligible for inclusion
- •For information about the NordICC trial see clinicaltrials.gov NCT00883792
Exclusion Criteria
- •Pregnancy
- •Persons younger than 18 years
- •Persons unable to comprehend the information given
- •not possible to start the examination without prior administration of sedation/analgesics
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Need for sedation/analgesics during the colonoscopy procedure(1 hour)
- Time used to reach the caecum(1 hour)
- Need to change to a different colonoscope to complete the procedure(10 minutes)
- Caecum intubation rate(30 minutes)
Study Sites (1)
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