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A study to compare carbon dioxide and a fluid as methods of opening the colon to allow inspection and diagnosis

A pilot study to compare carbon dioxide and a polyethylene glycol solution as methods of distending the colon for clinical investigation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN35449781
Enrollment
20
Registered
2012-08-22
Start date
2012-10-01
Completion date
Unknown
Last updated
2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Digestive System

Interventions

There will be two groups A and B, to which the 20 participants will be randomly allocated. Group A will be MRI scanned using the chosen fluid to distend the colon. A few hours later group A will be MR

Sponsors

University of Leeds (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
To compare patient tolerance of the use of fluid to open the colonic lumen with the use of CO2 insufflation

Secondary

MeasureTime frame
1. To assess the how well the two methods distend the colon measured by MRI scanning 2. To further demonstrate the safe use of Klean Prep as the fluid of choice for CoDIR 3. To investigate how filling the colon with fluid changes its dimensions when repositioning the patient 4. To assess patient tolerance of different positions following instillation of fluid

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026