CapaCiTY Study 1- Chronic Constipation Treatment Pathway
Research type
Research Study
Full title
RANDOMISED TRIAL OF HABIT TRAINING VS. HABIT TRAINING WITH DIRECT VISUAL BIOFEEDBACK IN ADULTS WITH CHRONIC CONSTIPATION
IRAS ID
160709
Contact name
Charlie Knowles
Contact email
Sponsor organisation
Barts Health NHS Trust
Duration of Study in the UK
3 years, 4 months, 29 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 nurse led habit training (HT) and nurse led biofeedback with habit training (HTBF), with approximately 227 patients randomised to each group. In addition, 146 patients will undergo radio-physiological investigations (INVEST)to diagnose functional defecation disorder (FDD) and be given HT or HTBF based on FDD diagnosis.
REC name
London - City & East Research Ethics Committee
REC reference
14/LO/1786
Date of REC Opinion
6 Dec 2014
REC opinion
Further Information Favourable Opinion