Extrait

Background and study aims Some degree of constipation affects nearly everyone at some stage in their life. However, some people suffer chronic (long term) symptoms that seriously impair their quality of life and which require medical intervention (treatment). Doctors use the term ‘chronic constipation’ to describe patients who have had symptoms for a long time (more than 6 months) and fail to respond to basic measures e.g. simple laxatives. This problem can affect 1 in 50 people, especially women and it can be remarkably difficult to treat effectively, even in specialist units. Current approaches include various new and old drugs, nurse-led bowel retraining programmes, bowel irrigation using special catheter systems, 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 professional guidance as to which patients should be offered which treatments and when. Further, the value of certain specialist (expensive and invasive) investigations to better 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. The aim of this research is test the effectiveness and cost-effectiveness of nurse led habit training (HT) and nurse led biofeedback training (HTBF) as a treatment for chronic constipation. Who can participate? Patients aged 18-70 with chronic constipation. What does the study involve? Patients are randomly allocated into one of two groups. Those in group 1 receive HT treatment. This involves giving each patient a leaflet covering normal bowel function, what causes constipation, advice on diet and fluid intake, how to get into a good bowel habit, posture, and defaecatory dynamics (what happens when a person moves their bowels) and pelvic floor exercises as appropriate. Those in group 2 receive HTBF treatment. All patients in group 2 receive the same leaflet as group 1 but are also given direct visual feedback during defaecatory dynamics coaching. A quarter of all patients taking part are also randomly selected to receive specialist radio-physiological tests to see whether they are suffering from a functional defecation disorder. For each treatment, the researchers collect detailed data on the effectiveness of reducing symptoms, patient acceptability and cost to the NHS .. Armed with this information, it will be possible by the end of the research to put all this evidence into an NHS guidance document, which can be used nationally as a treatment pathway to give the right care to the right patient at the right time. What are the possible benefits and risks of participating? The risks of participation are considered very low. The interventions proposed are those already offered to patients in specialist centres throughout the UK and internationally. The only difference conferred by participation is that these interventions will be randomly allocated and very carefully assessed. All interventions are safe. Patients receiving specialist investigations will undergo two X-ray procedures. The combined dose of radiation from these procedures is equivalent to less than 7 months annual background radiation dose from living in the UK. Further, these investigations would be carried out in routine clinical practice in many centres for patients with CC. Where is the study run from? Approximately ten NHS trusts in England. When is the study starting and how long is it expected to run for? July 2014 to June 2019 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? Ms Natasha Stevens [email protected]

Critère d'inclusion

• Topic: Primary Care, Gastroenterology; Subtopic: Gastroenterology, Gastroenterology; Disease: All Diseases, All Gastroenterology

Liens

• isrctn
• ictrp