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

NCT06100055 | Recruiting DMC

• 2 other identifiers: IRAS 324658324658
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Constipation - Functional; Constipation; Constipation by Outlet Obstruction; Defecation Disorder

Keywords

chronic constipation; rectal irrigation; evacuation disorders; low-volume rectal irrigation; high-volume rectal irrigation

Outcome Measures

Primary Outcomes (1)

• Patient Assessment of Constipation - Quality of Life questionnaire (PAC-QOL)

  PAC-QOL measures health related quality of life in patients with constipation. Lower score reflects better quality of life where it ranges from 0-112

  At baseline and after three months after using rectal irrigation

Secondary Outcomes (3)

• Patient Assessment of Constipation - Symptoms (PAC-SYM)

  At baseline and after three months of using rectal irrigation

• Obstructed Defaecation Syndrome - Score (ODS-S)

  At baseline and after three months of using rectal irrigation

• International Consultation on Incontinence Questionnaire Anal Incontinence Symptoms and Quality of Life Module (ICIQ-B)

  At baseline and after three months of using rectal irrigation

Study Arms (2)

Low-volume rectal irrigation

ACTIVE COMPARATOR

This system consists of a small reservoir attached to a cone. Depending on the manufacturer, the reservoir can hold approximately between 110ml and 300ml of water. This reservoir is squeezed to inject water into the rectum. The regime will be such that participants will be asked to use rectal irrigation daily for two weeks. They will be restricted to not use rectal irrigation for more than once in a day. Every day they can use up to 300ml for irrigation. After two weeks participants can then adjust the number of irrigation days per week as well as volume used for irrigation but not exceeding irrigation therapy more than once a day and not more than 300ml per irrigation. Volume and frequency of rectal irrigation will be recorded by participant in participant journal. This will be used to check their compliance and average weekly irrigation sessions and volume used for satisfactory outcome.

Device: Rectal Irrigation

High-volume rectal irrigation

ACTIVE COMPARATOR

The high-volume irrigation system consists of an irrigation bag connected to a tube. The water flows into the rectum, either by gravity or by using a pump. Some systems use balloon to hold the device in place during irrigation; others require the user to hold it in place. The mechanism of action is the same for all systems. Participants will start irrigation with 300ml and increase this by 100ml every 2 days until satisfactory defaecation is achieved, or the procedure becomes uncomfortable, up to a maximum of 1500ml. Initial frequency of irrigation is the same as for low-volume irrigation: i.e. once daily for two weeks followed by participant adjustment of number of irrigation days per week as well as volume used for irrigation but no more than 1500ml a day. Participants will be restricted to using high-volume irrigation to not more than once a day.

Device: Rectal Irrigation

Interventions

Rectal Irrigation DEVICE

Rectal irrigation is the introduction of warm tap water through the anal canal into the rectum to initiate defaecation. Two alternative irrigation systems based on volume delivered exist: low-volume irrigation system depending on the manufacturer delivers approximately between 110ml to 300ml per irrigation and high-volume irrigation system delivers between 300ml to 1500ml per irrigation.

Also known as: trans-anal irrigation

High-volume rectal irrigation; Low-volume rectal irrigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

St Thomas' Hospital

London, United Kingdom

RECRUITING

Related Publications (26)

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MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alison Hainsworth, FRCS

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tanzeela Gala, FCPS-Surgery

CONTACT

07496288119; tanzeela.gala@gstt.nhs.uk

Alison Hainsworth, FRCS

CONTACT

alison.hainsworth@gstt.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and clinicians will be aware of treatment allocations. The need to collect data on frequency and volume of irrigation, as well as reasons for discontinuing means that assessor blinding is not possible with respect to these outcomes. However, the statistician involved in the analysis will only receive coded data and therefore will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a superiority trial with parallel group design where each participant will receive only one of the two types of intervention (rectal irrigation).

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 25, 2023
• Study Start: May 10, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)