CapaCiTY Study 2- Chronic Constipation Treatment Pathway
Research type
Research Study
Full title
PRAGMATIC RANDOMISED TRIAL OF LOW VERSUS HIGH VOLUME INITIATED TRANS- ANAL IRRIGATION THERAPY IN ADULTS WITH CHRONIC CONSTIPATION
IRAS ID
172401
Contact name
Charles Knowles
Contact email
Sponsor organisation
Queen Mary, University of London
Duration of Study in the UK
3 years, 6 months, 31 days
Research summary
Some degree of constipation affects nearly everyone at some stage in their life. Some people suffer chronic symptoms that seriously impair their quality of life and which require medical intervention. Chronic constipation describes patients who have a longer duration of symptoms (more than 6 months) and who fail to respond to basic measures e.g. exercise, increased fluid intake, simple diet changes and laxatives. This problem may affect about 1 in 10 people, especially women, with about 1 in 50 people seeking specialist hospital management. Chronic constipation can be remarkably difficult to treat effectively, even in specialist units, resulting in a significant and sometimes severe impact on quality of life. Current approaches include laxatives and newer drugs, nurse-led bowel retraining programmes, bowel (anal) irrigation, and a variety of surgical operations that may have variable, and sometimes very poor, results. While there is current optimism that the situation for such patients will improve with several new treatments being developed (drugs and medical devices), there is a lack of evidence about which treatments should be offered to patients and when, and practice varies widely between centres. Further, the value of certain specialist (expensive and invasive) investigations which may help to understand the underlying cause of the constipation is also unclear. In a resource-constrained NHS, doctors and patients need to have confidence that new and sometimes expensive therapies are cost-effective and that the old ones actually work. This trial will assess the effectiveness and cost effectiveness of two different systems of trans-anal irrigation therapy (low volume and high volume). Approximately 300 patients will be radomised 1:1 to initiate therapy with one or other system. Before randomisation, patients will undergo radio-physiological investigations (INVEST) and the relationship between these test results and response to treatment will also be explored.
REC name
London - City & East Research Ethics Committee
REC reference
15/LO/0732
Date of REC Opinion
6 Jul 2015
REC opinion
Further Information Favourable Opinion