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Pragmatic Clinical Trials Unit

CapaCiTY

Full Title: Development of a UK evidence-based pathway for the management of chronic constipation in adults 

Short Title: Chronic Constipation Treatment pathwaY                                                                          

Chief Investigator: Professor Charles Knowles

Funder: NIHR Programme Grant for Applied Research

Funder Reference: RP-PG-0612-20001

Research Status

CapaCiTY01 - Closed to Recruitment, in Follow Up

CapaCiTY02 - Closed to Recruitment, in Follow Up

CapaCiTY03 - Open to Recruitment                                                                                                     

Some degree of constipation affects nearly everyone at some stage in their life. However, 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, specialist-led bowel retraining programmes, anal irrigation therapy, 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, 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 expensive and invasive specialist 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.

The aim of this programme of research is to recruit a large number of adult patients (about 800) with chronic constipation from at least 10 centres in England over 5 years.

The programme of research is made up of three important clinical trials of non-drug therapies, all aiming to reduce the symptoms of chronic constipation in adults.

CapaCiTY01: The first trial is comparing the effectiveness of two types of specialist-led bowel retraining, habit training and biofeedback.

 CapaCiTY02: The second trial is comparing the effectiveness of high volume and low volume anal irrigation.

 CapaCiTY03: The third trial is investigating the efficacy of laparoscopic ventral mesh rectopexy, a type of surgery for correcting internal rectal prolapse.

 Patients can take part in just one of the trials depending on their previous treatment or proceed through the trials in a stepwise fashion: i.e. if a patient fails to respond to one treatment they will move onto the next one. For each treatment, we will collect detailed data on the effectiveness of reducing symptoms of constipation, improvements in quality of life, patient acceptability and cost of treatment to the NHS. We will also determine the value of particular specialist investigations in being able to successfully guide treatment. Subsequently, we will synthesise our new evidence and published research findings to develop a guidance document for the NHS, which can be used nationally as a treatment pathway to provide effective care to patients in a timely fashion

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