Up to 10% of UK adults have chronic constipation that laxatives cannot fix, yet the NHS has no agreed pathway for what to do next. This matters because patients endure years of debilitating symptoms—pain, bloating, and severely reduced quality of life—while the health service spends heavily on disjointed, unproven treatments. No national guidance exists on which investigations or therapies work best, or in what order they should be offered. The research will recruit 1,000 patients from GP networks and specialist centres, then run a series of linked trials. One trial tests whether expensive radio-physiological investigations improve outcomes; another compares biofeedback with simpler habit training; later trials assess anal irrigation and, for non-responders, surgery. All use a standardised patient-reported outcome measure. If successful, the programme will produce the first evidence-based NHS treatment pathway for chronic constipation in adults. This would give GPs clear referral criteria, spare patients ineffective treatments, and reduce wasteful variation in care. The findings will be disseminated as guidance to the NHS—no NICE guideline currently exists for this condition.
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Aims and objectives The aim of this programme is to answer the important research questions relevant to an NHS evidence-based management of chronic constipation (CC) in adults and derive an appropriate and cost-effective pathway of care. Background and rationale CC - defined as more than 6 months of symptoms that are unresponsive to laxative therapy affects up to 10% of the population and is especially prevalent in women. CC leads to significantly impaired QOL and is a major consumer of healthcare resource. While many new treatments are emerging, there is almost no agreement (or published NHS guidance) as to which are most effective, what investigations are warranted, or in what order such investigations and interventions should be offered. The overall rationale of the programme is to develop an evidence base for CC management through a series of interlinked work packages (WPs) that answer these important questions. Research environment & team expertise The research team comprises leading UK clinicians in bowel management (primary care, gastroenterology, surgery, colorectal nursing, radiology, physiology, psychology and urogynaecology) together with broad methodological expertise. Trials will be managed by the Pragmatic Clinical Trials Unit at Barts Health NHS Trust and Queen Mary University of London. Research plan In WP1, national recruitment from primary care networks and approx. 10 specialist centres in England will provide (over 2.5 years) a large selected cohort of approximately 1000 well-defined patients for subsequent studies within parallel WPs. This cohort will be profiled at baseline for characteristics of interest per se and which may serve as outcome predictors. In WP2, 600 patients will be randomly allocated to 2 groups on the basis of whether they receive (INVEST: n=200) or do not receive (NO-INVEST: n=400) specialist radio-physiological investigations. A nested randomised trial of the 400 NO-INVEST patients will determine whether a more complex and expensive intervention (biofeedback with habit training) is more effective than a less complex one (habit training alone) in unselected CC patients. A comparison of these outcomes with those from the INVEST-stratified treatment arm will determine the added value of extensive investigation. In WP3, patients who have failed behavioral training will be recruited to a waiting list RCT of anal irrigation. Non-responders to anal irrigation will be eligible for waiting list RCTs of surgical interventions (WP4). These RCTs will determine short-term effectiveness of interventions and also response predictors that might target future treatment (by longitudinal follow up). All WPs will use a common, standardised outcome framework to assess the value of treatments, with a validated patient reported outcome score (PAC-QOL) providing the primary clinical outcome. Together, the WPs will generate real-life evidence using pragmatic studies to inform patient outcomes, acceptability and cost. In WP5, findings will be assimilated and synthesised with previous research, and a national working group convened to develop a new treatment pathway for management of CC in adults. The working group will identify best practice, remaining controversies and mechanisms for promoting the uptake of findings by the NHS. Project outputs and dissemination plans Summative findings will be disseminated as guidance to the NHS, promoting a new treatment pathway for the management of CC in adults (a NICE guideline for the management of CC in adults does not currently exist). While it is accepted that the programme will be conducted in secondary and tertiary settings, such guidance will directly affect primary care management by informing timely referral for further hospital-based investigations or treatment. A detailed plan at professional, patient and public levels will ensure broad dissemination of the programme findings. All scientific findings will be published in peer-reviewed a
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