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

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

doi:10.1186/s13063-017-1882-y

Cited by 16 publications

(4 citation statements)

References 54 publications

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“…167 Overall satisfaction was increased in 67% of patients; 39% reported being moderately better and 28% reported being very much better. Prospective controlled studies are underway 168 to evaluate different methods of irrigation and the costeffectiveness of transanal irrigation.…”

Section: Management Of Chronic Constipation Refractive To Medical Therapymentioning

confidence: 99%

Mechanisms, Evaluation, and Management of Chronic Constipation

2020

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Section: Management Of Chronic Constipation Refractive To Medical Therapymentioning

confidence: 99%

Mechanisms, Evaluation, and Management of Chronic Constipation

2020

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“…CapaCiTY02 (n = 300), a pragmatic randomised trial, compared low volume with high volume initiated anal irrigation therapy in adult patients with chronic constipation who did not respond to nurse-led biofeedback or bowel habit training. This was a parallel 2-arm trial (15). CapaCiTY03 (n = 114) used a stepped wedge individual level 3-arm randomised design to evaluate a surgical procedurelaparoscopic ventral mesh rectopexy in adults with chronic constipation(16, 17 We conducted site feasibility assessments [supplementary les 1,2,3] with sites prior to inclusion in the CapaCiTY programme.…”

Section: Methodsmentioning

confidence: 99%

A study within a trial (SWAT) of clinical trial feasibility and barriers to recruitment in the United Kingdom – the CapaCiTY programme experience

Stevens,

Taheri,

Grossi

et al. 2023

Preprint

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Background: Recruitment is the Achilles heel of clinical trials. Failure to recruit the planned sample jeopardises reliability of results and wastes significant time and resources. Site feasibility assessments are a common tool employed by sponsors to assess a site’s recruitment potential and ability to undertake the trial protocol. The purpose of this study was to evaluate site feasibility procedures as a tool for predicting recruitment potential. Methods: We conducted site feasibility assessments with thirty-nine sites across the UK. Twenty-seven were selected to participate in the CapaCiTY programme: three randomised controlled trials (01; ISRCTN11791740; 16/07/2015, 02; ISRCTN11093872; 11/11/2015, 03; ISRCTN11747152; 30/09/2015) aiming to develop an evidence based adult chronic constipation treatment pathway. We compared site feasibility-based predicted recruitment rates with actual recruitment rates and conducted a telephone survey (n=24) to understand barriers to recruitment. Results: Sites failed to accurately predict their recruitment potential during site feasibility. Conducting site feasibility did not result in the trials recruiting the required sample. At the time of survey, 17% of sites in CapaCiTY01 were meeting recruitment targets, 83% were recruiting half or less of their target. Of these, 17% recruited no participants. In CapaCiTY02, 13% of sites were recruiting to target, 87% were recruiting half or less; of these, 25% recruited no participants. In CapaCiTY03, 14% of sites were recruiting to target, 86% recruited half or less of the target, of these 43% recruited none. The main barriers to recruitment were lack of resources, high workloads, lack of suitable participants and study design not being compatible with routine care. Conclusions: Improving the reliability of site feasibility assessment could potentially save hundreds of millions of pounds each year in failed research investments and speed up the time to delivery of new treatments for patients. We recommend 1) conducting site feasibility assessment at the pre-award stage; 2) investment in training researchers in conducting and completing site feasibility; 3) funders to include clinical trial feasibility specialists on peer review and grants panels; 4) development of a national database of sites’ previous trial recruitment performance; 5) data-driven site level assessment of recruitment potential. Trial registration: ISRCTN11791740; 16/07/2015, ISRCTN11093872; 11/11/2015, ISRCTN11747152; 30/09/2015.

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“…It is common to consider 400-500 cm 3 of warm water to be an appropriate starting volume for irrigation in adults [27] but there is little evidence in the literature about optimal irrigation volumes. A randomized trial compared high-and lowvolume irrigations in adult patients with CC [28] but the volume of water and the frequency of administrations can vary depending on the patient's requirements and bowel disorder.…”

Section: Methodsmentioning

confidence: 99%

Sacral and Percutaneous Tibial Nerve Stimulation, Stem Cell Therapy, and Transanal Irrigation Device

et al. 2022

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The early experiences with sacral nerve stimulation for refractory overactive bladder (OAB) [1] by urologists stimulated colorectal surgeons to use this procedure also for bowel dysfunctions, such as fecal incontinence (FI) [2] and chronic constipation (CC) [3,4]. The first experience for FI was described by Matzel [2], and then the International Consultation on Incontinence in 2013 introduced sacral nerve stimulation (SNS) as a first-line treatment for FI in patients without or with minimal sphincter defect and as a second choice in those with moderate or large defects [5]. How It WorksThe sacral nerves S2-S4 modulate pelvic sensitivity and the motility of the urologic and gastrointestinal functions of the pelvic floor. Electrical stimulation of the sacral roots creates a modulation of motor, sensory and autonomous nerve pathways in both the peripheral and central system, accounting for good outcomes in such different conditions as FI, CC, OAB, urinary incontinence, and low anterior resection syndrome (LARS) [6].

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

Cited by 16 publications

References 54 publications

Mechanisms, Evaluation, and Management of Chronic Constipation

Mechanisms, Evaluation, and Management of Chronic Constipation

A study within a trial (SWAT) of clinical trial feasibility and barriers to recruitment in the United Kingdom – the CapaCiTY programme experience

Sacral and Percutaneous Tibial Nerve Stimulation, Stem Cell Therapy, and Transanal Irrigation Device

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