Comparing low-volume and high-volume rectal irrigation for chronic constipation
The ReVo Study (REctal Irrigation VOlume Study - 'Low Versus High Volume Irrigation - Optimising Rectal Irrigation Volume in Evacuatory Dysfunction'; A Randomised Controlled Trial)
This study tests whether low-volume or high-volume rectal irrigation helps adults with chronic constipation feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 166 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (London) |
| Trial ID | NCT06100055 on ClinicalTrials.gov |
What this trial studies
This trial compares the effectiveness of low-volume versus high-volume rectal irrigation in adults suffering from chronic constipation due to evacuation disorders. Participants will be randomly assigned to receive either type of irrigation, and their outcomes will be assessed over three months. The study aims to evaluate the impact on quality of life and symptom severity, as well as compliance and reasons for discontinuation. It seeks to determine if one method is superior to the other for specific patient subgroups identified through pelvic floor ultrasound.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with chronic constipation due to evacuation disorders who have not responded to conservative treatments.
Not a fit: Patients with recent major colorectal surgeries, pregnancy, active rectal bleeding, or colorectal cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clearer guidelines for treating chronic constipation, potentially improving patient outcomes and quality of life.
How similar studies have performed: While the concept of rectal irrigation is established, this specific comparison of low-volume versus high-volume irrigation is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All adult patients over 18 years who have self-reported problematic constipation secondary to evacuation disorders * With symptom onset of more than 6 months * Symptoms must meet American College of Gastroenterology definition of constipation which is symptoms including unsatisfactory defecation with either infrequent stools, difficulty in passing stool or both for at least previous 3 months (25) * All should have tried and failed conservative management (laxatives, life-style modification and bio-feedback) * Patients should also have ability and willingness to give informed consent. * Patients or carer should be able to use rectal irrigation Exclusion Criteria: Patients with * Major colorectal resection surgery, pelvic floor surgery to address defaecatory problems such as posterior vaginal repair, STARR, rectopexy and sacral nerve stimulation within last three months * Pregnancy * Active rectal bleeding * Colorectal cancer * Complicated diverticular disease or acute diverticulitis * Anal or colorectal stenosis * Inflammatory bowel disease * Undergoing chemotherapy * Ischemic colitis * Used rectal irrigation in the past one year
Where this trial is running
London
- St Thomas' Hospital — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Alison Hainsworth, FRCS — Guy's and St Thomas' NHS Foundation Trust
- Study coordinator: Tanzeela Gala, FCPS-Surgery
- Email: tanzeela.gala@gstt.nhs.uk
- Phone: 07496288119
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.