Abstract
BackgroundConstipation is common in adults and up to 20% of the population report this symptom. Chronic constipation (CC), usually defined as more than 6 months of symptoms, is less common but results in 0.5 million UK GP consultations per annum. The effect of symptoms on measured quality of life (QOL) is significant, and CC consumes significant health care resources. In the UK, it is estimated that 10% of district nursing time is spent on constipation. Trans-anal irrigation therapy has become a widely used treatment despite a lack of robust efficacy data to support its use. The long-term outcome of treatment is also unclear. A randomised comparison of two different methods of irrigation (high- and low-volume) will provide valuable evidence of superiority of one system over the other, as well as providing efficacy data for the treatment as a whole.MethodsParticipants will be recruited based on predetermined eligibility criteria. Following informed consent, they will be randomised to either high-volume (HV) or low-volume (LV) irrigation and undergo standardised radiological and physiological investigations. Following training, they will commence home irrigation with the allocated device. Data will be collected at 1, 3, 6 and 12 months according to a standardised outcomes framework. The primary outcome is PAC-QOL, measured at 3 months. The study is powered to detect a 10% difference in outcome between systems at 3 months; this means that 300 patients will need to be recruited.DiscussionThis study will be the first randomised comparison of two different methods of trans-anal irrigation. It will also be the largest prospective study of CC patients treated with irrigation. It will provide evidence for the effectiveness of irrigation in the treatment of CC, as well as the comparative effectiveness of the two methods. This will enable more cost-effective and evidence-based use of irrigation. Also, the results will be combined with the other studies in the CapaCiTY programme to generate an evidence-based treatment algorithm for CC in adults.Trial registrationISRCTN, identifier: ISRCTN11093872. Registered on 11 November 2015. Trial not retrospectively registered. Protocol version 3 (22 January 2016).
Highlights
Constipation is common in adults and up to 20% of the population report this symptom
Patient dissatisfaction is high in this group; nearly 80% feel that laxative therapy is unsatisfactory [11] and the effect of symptoms on measured quality of life (QOL) is significant [12]
Significant organic colonic disease (‘red flag’ symptoms, e.g. rectal bleeding previously investigated); inflammatory bowel disease (IBD); megacolon or megarectum; severe diverticulosis/ stricture/birth defects deemed to contribute to symptoms
Summary
Setting Specialist centres across the UK with a mix of urban and rural referral bases. Patient Health Questionnaire-9 (PHQ-9) [53,54,55] Generalised Anxiety Disorder Questionnaire (GAD-7) [56] Depression, anxiety and somatisation modules of the Patient Health Questionnaire [53,54,55,56] and the Illness Perception Questionnaire [57] Global patient satisfaction/improvement score (VAS) and whether they would recommend each treatment experienced to other patients Potentially modifiable cognitive and behavioural psychological variables shown to predict onset and perpetuation of other functional bowel symptoms: negative perfectionism, avoidant and ‘all or nothing’ behaviour subscales of the Behavioural Response to illness Questionnaire (CC-BRQ), and the Brief Illness Perception Questionnaire BIPQ (CC) A 2-week Patient Diary (for 2 weeks prior to each assessment at 3, 6 and 12 months) to record bowel frequency and whether each evacuation was spontaneous (no use of laxatives) and/or complete; the patient journal will capture concurrent medication, health contacts, and time away from normal activities (including work).
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