Evidence map›Paper›PMID 28359279›Full record

Trial reportTrials2017

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

Christopher Emmett, Helen Close, James Mason, Shiva Taheri, Natasha Stevens, Sandra Eldridge, Christine Norton, Charles Knowles, Yan Yiannakou

Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06100055 (The ReVo Study), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.3field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06100055 naunknown statusnot on this mapstarted 2024, after this paper: background citation

The ReVo Study (REctal Irrigation VOlume Study - 'Low Versus High Volume Irrigation - Optimising Rectal Irrigation Volume in Evacuatory Dysfunction'; A Randomised Controlled Trial)

TypeinterventionalSponsorGuy's and St Thomas' NHS Foundation TrustRan2024 to 2025Enrolled166ConditionsConstipation - Functional, Constipation, Constipation by Outlet Obstruction, Defecation DisorderArmsRectal Irrigation
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 19 citations in OpenAlex.

  1. Article
  2. Constipation and Fecal Incontinence in the Elderly.Current gastroenterology reports · 2020
    Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 1 country.

Christopher EmmettUniversity Hospital of North Durham, North Road, Durham, DH1 5TW, UK. Christopher.Emmett@nhs.net.
Helen CloseSchool of Medicine, Pharmacy and Health, Durham University Queen's Campus, University Boulevard, Thornaby, Stockton-on-Tees, TS17 6BH, UK.
James MasonWMS - Population Evidence and Technologies, University of Warwick, Coventry, CV4 7AL, UK.
Shiva TaheriBlizard Institute, Queen Mary University of London, 1st Floor Abernethy Building, 2 Newark St, London, E1 2AT, UK.
Natasha StevensBlizard Institute, Queen Mary University of London, 1st Floor Abernethy Building, 2 Newark St, London, E1 2AT, UK.
Sandra EldridgeBlizard Institute, Barts and The London School of Medicine and Dentistry, Yvonne Carter Building, 58 Turner St., London, E1 2AB, UK.
Christine NortonKings College London, 2.25 James Clerk Maxwell Building, 57 Waterloo Road, London, SE1 8WA, UK.
Charles KnowlesBlizard Institute, Queen Mary University of London, 1st Floor Abernethy Building, 2 Newark St, London, E1 2AT, UK.
Yan YiannakouUniversity Hospital of North Durham, North Road, Durham, DH1 5TW, UK.
Queen Mary University of London · GBUniversity Hospital of North Durham · GBDurham University · GBKing's College London · GBUniversity of Warwick · GB

Funding

Department of Health RP-PG-0612-20001
6 · The paper itself

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. 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 registrationISRCTN, identifier: ISRCTN11093872 . Registered on 11 November 2015. Trial not retrospectively registered. Protocol version 3 (22 January 2016).

Indexed as

DefecationAdolescentAdultAgedChronic DiseaseClinical ProtocolsConstipationEquipment DesignFemaleHumansMaleMiddle AgedProspective StudiesQuality of LifeRecovery of FunctionResearch DesignChronicConstipationIrrigation

Identifiers

PMID28359279
PMCPMC5374566
OpenAlexW2602702457

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.