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Search / Trial NCT06100055

The ReVo Study: Low-volume vs High-volume Rectal Irrigation

Launched by GUY'S AND ST THOMAS' NHS FOUNDATION TRUST · Oct 19, 2023

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Chronic Constipation Rectal Irrigation Evacuation Disorders Low Volume Rectal Irrigation High Volume Rectal Irrigation

ClinConnect Summary

The ReVo Study is researching two types of rectal irrigation—low-volume and high-volume—to see which one works better for people with chronic constipation that makes it hard to empty the bowels. Rectal irrigation involves using warm water introduced through the anus to help stimulate bowel movements. This study aims to compare the effectiveness and acceptability of both methods in patients who have not found relief from traditional treatments like laxatives or lifestyle changes.

To participate, you need to be an adult over 18 years old with a history of constipation lasting more than six months that hasn’t improved with other treatments. If you join, you will be randomly assigned to either the low-volume or high-volume group and will receive training on how to use the assigned method at home. Throughout the study, you’ll fill out questionnaires about your quality of life and undergo a pelvic floor ultrasound to help understand your symptoms better. After three months of using the irrigation method, you’ll have follow-up assessments to see if your symptoms have improved. This study is currently recruiting participants of all genders aged 18 and older.

Gender

ALL

Eligibility 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

About Guy's And St Thomas' Nhs Foundation Trust

Guy's and St Thomas' NHS Foundation Trust is a leading healthcare organization in the United Kingdom, renowned for its commitment to delivering high-quality patient care, innovative research, and clinical excellence. As a prominent academic health science center, the Trust integrates cutting-edge research with clinical practice, facilitating the translation of scientific discoveries into improved treatment options. With a diverse portfolio of clinical trials across various medical specialties, Guy's and St Thomas' NHS Foundation Trust plays a pivotal role in advancing healthcare knowledge and enhancing patient outcomes, while maintaining the highest ethical standards in research and patient safety.

Locations

London, , United Kingdom

Patients applied

0 patients applied

Trial Officials

Alison Hainsworth, FRCS

Principal Investigator

Guy's and St Thomas' NHS Foundation Trust

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported