title: Low-volume versus high-volume initiated trans-anal irrigation therapy in adults with chronic constipation: study protocol for a randomised controlled trial.
abstract: Constipation 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.
  
  
  
  Participants 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.
  
  
  
  This 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.
  
  
  
  ISRCTN, identifier: ISRCTN11093872 . Registered on 11 November 2015. Trial not retrospectively registered. Protocol version 3 (22 January 2016).
authors.affiliation: University Hospital of North Durham, North Road, Durham, DH1 5TW, UK. Christopher.Emmett@nhs.net.
authors.forename: Christopher
authors.initials: C
authors.lastname: Emmett
authors.affiliation: School of Medicine, Pharmacy and Health, Durham University Queen's Campus, University Boulevard, Thornaby, Stockton-on-Tees, TS17 6BH, UK.
authors.forename: Helen
authors.initials: H
authors.lastname: Close
authors.affiliation: WMS - Population Evidence and Technologies, University of Warwick, Coventry, CV4 7AL, UK.
authors.forename: James
authors.initials: J
authors.lastname: Mason
authors.affiliation: Blizard Institute, Queen Mary University of London, 1st Floor Abernethy Building, 2 Newark St, London, E1 2AT, UK.
authors.forename: Shiva
authors.initials: S
authors.lastname: Taheri
authors.affiliation: Blizard Institute, Queen Mary University of London, 1st Floor Abernethy Building, 2 Newark St, London, E1 2AT, UK.
authors.forename: Natasha
authors.initials: N
authors.lastname: Stevens
authors.affiliation: Blizard Institute, Barts and The London School of Medicine and Dentistry, Yvonne Carter Building, 58 Turner St., London, E1 2AB, UK.
authors.forename: Sandra
authors.initials: S
authors.lastname: Eldridge
authors.affiliation: Kings College London, 2.25 James Clerk Maxwell Building, 57 Waterloo Road, London, SE1 8WA, UK.
authors.forename: Christine
authors.initials: C
authors.lastname: Norton
authors.affiliation: Blizard Institute, Queen Mary University of London, 1st Floor Abernethy Building, 2 Newark St, London, E1 2AT, UK.
authors.forename: Charles
authors.initials: C
authors.lastname: Knowles
authors.affiliation: University Hospital of North Durham, North Road, Durham, DH1 5TW, UK.
authors.forename: Yan
authors.initials: Y
authors.lastname: Yiannakou
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002908:Chronic Disease; D002985:Clinical Protocols; D003248:Constipation / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D003672:Defecation; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D020127:Recovery of Function; D012107:Research Design; D011795:Surveys and Questionnaires; D007507:Therapeutic Irrigation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom; D055815:Young Adult
keywords: Chronic; Constipation; Irrigation