A study to compare carbon dioxide and a fluid as methods of opening the colon to allow inspection and diagnosis
Not Applicable
Completed
- Conditions
- GastrointestinalDigestive System
- Registration Number
- ISRCTN35449781
- Lead Sponsor
- niversity of Leeds (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
1. Aged 18-30
2. Subjects will predominantly be sourced from Leeds Medical School allowing their exposure to clinical trials during their training.
Exclusion Criteria
1. For anatomical reasons: history of GI disease or abdominal or pelvic surgery
2. For biochemical reasons: history of chronic cardiac or renal disease
3. Contraindications for the use of buscopan: allergy to buscopan
4. History of acute angle closure glaucoma, porphyria, myasthenia gravis and unstable cardiac disease
5. Ethical considerations: non consent for trial or unable to consent for trial
6. MRI considerations: any metal, cosmetic or therapeutic, will be an absolute contraindication, claustrophobia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare patient tolerance of the use of fluid to open the colonic lumen with the use of CO2 insufflation
- Secondary Outcome Measures
Name Time Method 1. To assess the how well the two methods distend the colon measured by MRI scanning<br>2. To further demonstrate the safe use of Klean Prep as the fluid of choice for CoDIR <br>3. To investigate how filling the colon with fluid changes its dimensions when repositioning the patient<br>4. To assess patient tolerance of different positions following instillation of fluid