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Compares treatment options for Constipation - Functional
Official title The ReVo Study: Low-volume vs High-volume Rectal Irrigation
ClinicalTrials.gov ID: NCT06100055
What this study is testing
- What it's testing
- 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, which is refractory to conservative measures such as lifestyle modification, laxatives, nurse-led bowel retraining programmes which focuses on bio-feedback as well as psychosocial support. Two systems of rectal irrigation are available based on volume delivered, low and high volume.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- Patients with
- Major colorectal resection surgery, pelvic floor surgery to address defaecatory problems such as posterior vaginal repair, STARR, rectopexy and...
- Pregnancy
- Active rectal bleeding
- Colorectal cancer
- Complicated diverticular disease or acute diverticulitis
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.