The ReVo Study: low-volume vs high-volume rectal irrigation
Research type
Research Study
Full title
The ReVo Study (REctal Irrigation VOlume Study – ‘low versus high volume irrigation - optimising rectal irrigation volume in evacuatory dysfunction’; A Randomised Controlled Trial)
IRAS ID
324658
Contact name
Alison/A Hainsworth
Contact email
Sponsor organisation
Guy's & St Thomas's NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 1 days
Research summary
Constipation is common and reported by up to 20% of adults. Chronic constipation (CC), which is more than six months of symptoms, results in 0.5 million GP consultations in a year in the UK. A small proportion of the population (1-2%) suffers from symptoms which are chronic and disabling, leading to higher patient dissatisfaction. Nearly 80% of this cohort feels that laxative therapy is unsatisfactory, with a significant impact of symptoms upon the measured quality of life (QOL). CC consumes substantial healthcare resources. In the UK, it is estimated that 10% of district nursing time is spent on constipation alone.
Chronic constipation secondary to evacuatory disorders can be difficult to treat effectively, even in specialist units. Current approaches include laxatives and newer drugs, nurse-led bowel retraining programs, rectal irrigation and a variety of surgical operations that may have variable and sometimes very poor results.
While there is current optimism that the situation for such patients will improve with several new treatments being developed (drugs and medical devices), there is a lack of evidence about which treatments should be offered to patients and when, and practice varies widely between centres. Further, the value of certain specialist (expensive and invasive) investigations that may help understand the underlying cause of constipation is also unclear. In a resource-constrained NHS, doctors and patients need to have confidence that new and sometimes expensive therapies are effective.
This trial will assess the effectiveness of the two different systems of rectal irrigation therapy (low-volume and high-volume). 166 patients will be randomized, 1:1, to initiate rectal irrigation therapy with one or another system. Before randomization, patients will undergo total integrated pelvic floor ultrasound and the relationship between the test results, and response to treatment will also be explored.
REC name
West of Scotland REC 4
REC reference
23/WS/0176
Date of REC Opinion
23 Jan 2024
REC opinion
Further Information Favourable Opinion