Epidemiology of constipation (EPOC) study in the United States: relation of clinical subtypes to sociodemographic features.
W F Stewart, J N Liberman, R S Sandler...
https://pubmed.ncbi.nlm.nih.gov/10606315Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06100055
The ReVo Study Low Versus High Volume Rectal Irrigation to Optimize Treatment for Evacuatory Dysfunction A Randomised Controlled Trial
Led by Guy's and St Thomas' NHS Foundation Trust · Updated on 2024-07-29
166
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two types of rectal irrigation—low-volume and high-volume—to treat chronic constipation caused by problems emptying the rectum. This study aims to find out if one type is better than the other, whether certain pelvic floor conditions affect outcomes, and how acceptable the treatments are to patients. The study focuses on adults with chronic constipation who have not improved with other treatments like lifestyle changes or laxatives. Participants are randomly assigned to use either a low-volume system (110ml to 300ml of water) or a high-volume system (starting at 300ml and increasing up to 1500ml) for rectal irrigation. Both groups use irrigation once daily for two weeks, then adjust frequency and volume within set limits for three months. Training on how to use the assigned irrigation system is provided, and participants record their use and any side effects in a journal. Participants complete quality-of-life and symptom questionnaires at the start and after three months of treatment. They undergo pelvic floor ultrasound to assess their condition before starting irrigation. Researchers monitor adherence, side effects, and symptom changes throughout. The study ends after three months of irrigation use, with follow-ups to collect data on effectiveness and safety. Data privacy is maintained, and participants can withdraw anytime without affecting their regular care.
CONDITIONS
Brief Title
The ReVo Study: Low-volume vs High-volume Rectal Irrigation
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults over 18 years with self-reported problematic constipation due to evacuation disorders
- Symptoms present for more than 6 months
- Symptoms meet American College of Gastroenterology criteria for constipation for at least the past 3 months
- Tried and failed conservative treatments including laxatives, lifestyle changes, and bio-feedback
- Ability and willingness to give informed consent
- Participant or carer able to use rectal irrigation
You will not qualify if you...
- Major colorectal or pelvic floor surgery within the last 3 months
- Pregnancy
- Active rectal bleeding
- Colorectal cancer
- Complicated or acute diverticular disease
- Anal or colorectal stenosis
- Inflammatory bowel disease
- Undergoing chemotherapy
- Ischemic colitis
- Used rectal irrigation in the past year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 telephone or in-person visit
Baseline Assessment and Training
Duration - 1 day
Participants attend a face-to-face visit for baseline assessments, including medical history, physical examination, questionnaires, pelvic floor ultrasound, randomisation, and training on rectal irrigation use.
1 face-to-face visit
Treatment
Duration - 3 months
Participants use either low-volume or high-volume rectal irrigation daily at home for the first two weeks, then adjust frequency and volume as needed, recording use and side effects in a participant journal.
Daily use at home with telephone follow-up 1 week after training
Follow-up Assessment
Duration - 1 day
Participants attend a face-to-face visit to complete outcome questionnaires and return the participant journal, ending their participation in the trial and returning to routine care.
1 face-to-face visit at 3 months
Trial Site Locations
Total: 1 location
1
St Thomas' Hospital
London, United Kingdom
Actively Recruiting
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Research Team
T
Tanzeela Gala, FCPS-Surgery
A
Alison Hainsworth, FRCS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Epidemiology of constipation in the United States.
A Sonnenberg, T R Koch
https://pubmed.ncbi.nlm.nih.gov/2910654Epidemiology of childhood constipation: a systematic review.
Maartje M van den Berg, M A Benninga, C Di Lorenzo
https://pubmed.ncbi.nlm.nih.gov/17032205Some determinants of whole-gut transit time: a population-based study.
C S Probert, P M Emmett, K W Heaton
https://pubmed.ncbi.nlm.nih.gov/7796084Chronic constipation: overview and challenges.
I J Cook, N J Talley, M A Benninga...
https://pubmed.ncbi.nlm.nih.gov/19824933A multinational survey of prevalence and patterns of laxative use among adults with self-defined constipation.
A Wald, C Scarpignato, S Mueller-Lissner...
https://pubmed.ncbi.nlm.nih.gov/18644012Health-related quality of life in functional GI disorders: focus on constipation and resource utilization.
E J Irvine, S Ferrazzi, P Pare...
https://pubmed.ncbi.nlm.nih.gov/12190165Surgery for constipation: systematic review and clinical guidance: Paper 1: Introduction & Methods.
C H Knowles, U Grossi, E J Horrocks...
https://pubmed.ncbi.nlm.nih.gov/28960925Surgical management of constipation.
C H Knowles, P G Dinning, M Pescatori...
https://pubmed.ncbi.nlm.nih.gov/19824939Outcome of colectomy for slow transit constipation.
C H Knowles, M Scott, P J Lunniss
https://pubmed.ncbi.nlm.nih.gov/10561086