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

Study acronym: ReVo
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Notable Primary completion date changed from estimate of Jul 2025 to Jun 30, 2026 Show 9 more changesShow less
    • Lead sponsor: Guy's and St Thomas' NHS Foundation Trust to Guy's and St Thomas' NHS Foundation Trust
    • Study completion date changed from estimate of Jul 2025 to Jul 30, 2026
    • Trial status changed: Unknown → Completed
    • Enrollment target: estimated 166 to confirmed 180
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 2 of 3 entries
    • Site details revised
    • Publications: details revised at 25 of 26 entries
    • Study description expanded, about 3 words
  2. Minor Changed Registry marked status Unknown; last known: Recruiting
  3. Minor Trial status: Not Yet Recruiting to Unknown
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 2024 to May 10, 2024
    v3
  4. Notable Start date: Nov 2023 to Mar 2024v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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. It is unknown if one type of irrigation is superior to the other and whether one type has better outcomes in patients with a particular pathology. Therefore, a comparison is required between the two types of irrigation to assess their acceptability as a therapy and response rates in patients with chronic constipation secondary to difficulty emptying rectum. This trial/research aims to compare low-volume rectal irrigation with high-volume rectal irrigation in patients with chronic constipation secondary to disorders of difficulty emptying rectum. The main questions it aims to answer are: * if one type of rectal irrigation is superior to the other * whether one type of rectal irrigation has better outcomes in patients with a particular pathology on pelvic floor ultrasound * assess the acceptability and response rates to rectal irrigation. Participants upon recruitment will be allocated to either low-volume rectal irrigation or high volume rectal irrigation groups. This will purely be by chance where the possibility of being in either of the groups will be 50%. They will then undergo a baseline assessment with four quality-of-life questionnaires and clinical examination. Following this a pelvic floor ultrasound will be performed to assess the cause of their symptoms. Lastly they will be provided training on using rectal irrigation (the type they have been assigned to). They will then be asked to commence irrigation at home from the next day. Participants will continue to use irrigation for three months and then have a three-monthly follow-up where the quality of life questionnaires will be filled again. This data will then be used to assess any improvement in symptoms after using rectal irrigation. After three months of using rectal irrigation, participation in the trial will come to and end.
Trial Details
NCT Number NCT06100055
Lead Sponsor Guy's and St Thomas' NHS Foundation Trust
Conditions
(from sponsor)
Constipation - Functional, Constipation, Constipation by Outlet Obstruction, Defecation Disorder
Related terms Constipation
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov