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01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Trials 1/2017

Low-volume versus high-volume initiated trans-anal irrigation therapy in adults with chronic constipation: study protocol for a randomised controlled trial

Zeitschrift:
Trials > Ausgabe 1/2017
Autoren:
Christopher Emmett, Helen Close, James Mason, Shiva Taheri, Natasha Stevens, Sandra Eldridge, Christine Norton, Charles Knowles, Yan Yiannakou
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s13063-017-1882-y) contains supplementary material, which is available to authorized users.

Abstract

Background

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.

Methods

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.

Discussion

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.

Trial registration

ISRCTN, identifier: ISRCTN11093872. Registered on 11 November 2015. Trial not retrospectively registered. Protocol version 3 (22 January 2016).
Zusatzmaterial
Additional file 1: CapaCiTY programme overview. (DOCX 152 kb)
13063_2017_1882_MOESM1_ESM.docx
Additional file 2: SPIRIT Checklist. (DOCX 66 kb)
13063_2017_1882_MOESM2_ESM.docx
Additional file 3: Communication organogram for reporting serious adverse events (SAEs). (DOCX 52 kb)
13063_2017_1882_MOESM3_ESM.docx
Additional file 4: Consent Form (quantitative study). (DOCX 64 kb)
13063_2017_1882_MOESM4_ESM.docx
Additional file 5: Consent Form (qualitative study). (DOCX 62 kb)
13063_2017_1882_MOESM5_ESM.docx
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