Reducing painful visual examinations of the large intestine in women who are attending in a bowel cancer screening program
- Conditions
- Many women are experiencing pain under colonoscopy. The present study aims to reduce pain in women undergoing colonoscopy in a bowel cancer screening program in Norway.Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
- Registration Number
- EUCTR2016-005090-13-NO
- Lead Sponsor
- Cancer Registry of Norway
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 420
All women attending colonoscopy in the Bowel cancer screening in Norway (BCSN) are eligible for the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 250
Exclusion criteria are identical to those in BCSN: Potential exclusion criteria are: Former open colon/rectum surgery; individuals in chronic need of care; ongoing chemo- or radiotherapy for malignant disease; chronic heart-/lung disease NYHA III-IV; individuals with heart valve implant and lifelong anticoagulation; coronary attack with need for hospitalization within the last 3 months; cerebrovascular event within
the last 3 months; domiciled outside the screening area; in addition allergy to Fentanyl or Rapifen
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method