Extrait

Background and study aims Constipation is a common condition which affects most people at some point in their lives. Chronic constipation is where the sufferer has been affected for at least six months, and basic treatments such as medications (laxatives), exercise and diet changes are ineffective. Another type of therapy is behaviour therapy, where a nurse helps the sufferer to use their muscles properly while straining. This type of therapy can be very effective, although it can be very time-consuming and may interfere with a patient’s day to day life. Anal irrigation, also known as trans-anal irrigation, is a technique where waste material (faeces) is flushed out of the bowel. During the procedure, water is pumped into the bowel through a tube inserted into the rectum (bottom), which essentially “rinses” it. The water is then removed from the bowel, taking the faeces with it. This type of procedure can be done using a large amount of water (high volume trans-anal irrigation) or a smaller amount of water (low volume trans-anal irrigation. The high volume technique is able to reach more of the bowel, but many patients are not able to cope with the procedure. The low volume technique only reaches the lower part of the bowel but it does cause the patient as much discomfort. The aim of this study is to compare the high and low volume techniques of anal irrigation in patients with chronic constipation to find out which is the most effective and cost-effective procedure. Who can participate? Adults with chronic constipation who are unresponsive to nurse-led behavioural therapy and are willing to try anal irrigation. What does the study involve? Participants are randomly allocated to one of two groups. Those in the first group undergo low volume anal irrigation and those in the second group undergo high volume anal irrigation. At the start of the study and three months after the anal irrigation procedure, participants in both groups are asked to complete a questionnaire to assess their quality of life. What are the possible benefits and risks of participating? Participants benefit from receiving a very high standard of monitored care throughout the study. There are very minor risks of undergoing anal irrigation, however there is a small risk of pain, bleeding, painful haemorrhoids and anal fissure (tear). Where is the study run from? 12 hospitals in England (UK) When is the study starting and how long is it expected to run for? August 2015 to February 2019 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? Mrs Shiva Taheri [email protected]

Critère d'inclusion

• Topic: Surgery, Gastroenterology; Subtopic: Gastroenterology; Disease: All Gastroenterology

Liens

• isrctn
• ictrp