Status:
RECRUITING
The ReVo Study: Low-volume vs High-volume Rectal Irrigation
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Conditions:
Constipation - Functional
Constipation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Rectal irrigation, which is the introduction of warm tap water through the anal canal into the rectum to initiate defaecation, is recommended to be considered in patients with chronic constipation, wh...
Detailed Description
Rectal irrigation(RI) is introducing warm tap water through the anal canal into the rectum to initiate defaecation. It is recommended that rectal irrigation be considered in patients with evacuation d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT06100055
Start Date
May 10 2024
End Date
July 1 2025
Last Update
July 29 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
St Thomas' Hospital
London, United Kingdom