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Reclassifying Constipation Using Magnetic Resonance Imaging Combined With High Resolution Manometry: A Validation Study And Double-Blind Crossover Trial (RECLAIM)
Constipation is a common condition in which an individual suffers with hard stools which are infrequent and difficult to pass. It is poorly understood and treatment is often unsatisfactory. Many patients also experience pain whilst others do not but it is unclear why . It is believed that the pain arises from contractions in the colon, the lower part of the intestines. Some patients with constipation have weak colonic contraction but surprisingly some, particularly those with a lot of pain have strong contractions which are poorly coordinated. These patients all suffer from constipation but would are likely to need very different treatments. At present we cannot identify what type of abnormality of colonic contractions each individual patient suffers from and so are unable to give them the best treatment. This study will take advantage of two new techniques which have been recently developed. Magnetic Resonance Imaging (MRI) which will allow us to see the contractions of the colon in response to a dose of the laxative Moviprep which increases the flow of fluid into the proximal part of the colon and High Resolution Manometry (HRM) which measures the power and direction of the contraction in much more detail than ever before using a pressure sensing catheter placed into the bowel. Using these 2 techniques we will identify the pattern of contractions in 80 patients with constipation and 40 healthy controls. Participants will then enter into a controlled trial of either a drug which stimulates contractions or one which inhibits contraction. We anticipate that the pattern of contractions identified by the non-invasive MRI technique will predict which treatment will reduce their symptoms most as effectively as the more invasive HRM. If this is the case then our MRI test of colonic responsiveness could become widely used in routine clinical practice
Details
| Lead sponsor | University of Nottingham |
|---|---|
| Phase | NA |
| Status | UNKNOWN |
| Enrolment | 120 |
| Start date | 2017-07-20 |
| Completion | 2021-06 |
Conditions
- Constipation - Functional
- Irritable Bowel Syndrome Characterized by Constipation
Interventions
- MRI Motility
- High Resolution Manometry
- Bisacodyl
- Hyoscine butylbromide
Primary outcomes
- MRI Endpoint: Maximal MRI Motility Index (MMI) of the ascending colon (AC) — During MRI scan (over 3 hours)
MRI Measure of Colonic Motility - HRM Endpoint: Percentage time occupied by cyclical propagating activity following meal — During manometry recording (over 6 hours)
Manometry recording of colonic motility - Difference in average worst daily pain, scored on a range 1-5 between buscopan and bisacodyl intervention periods. — Over 10 day period
Countries
United Kingdom