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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuy's and St Thomas' NHS Foundation Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

166 Participants
are divided into 2 treatment groups
Group A: Low-volume rectal irrigationActive comparator 1 intervention
Group B: High-volume rectal irrigationActive comparator 1 intervention

Trial outcomes

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

Time frame
At baseline and after three months after using rectal irrigation

Secondary outcomes

1

Patient Assessment of Constipation - Symptoms (PAC-SYM)

PAC-SYM questionnaire assesses the severity of patient reported symptoms of constipation where score ranges from 0-48 where higher scores indicate more severe symptoms

Time frame
At baseline and after three months of using rectal irrigation
2

Obstructed Defaecation Syndrome - Score (ODS-S)

This questionnaire will be used to diagnose presence of Obstructive Defaecation Syndrome. A score \>9 is diagnostic of ODS

Time frame
At baseline and after three months of using rectal irrigation
3

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

Evaluates symptoms of anal incontinence and its impact on quality of life (QOL). Scores from 1-21 for bowel pattern, 0-28 for bowel control and 0-26 for impact on quality of life associated with anal incontinence symptoms where higher score is suggestive of worse quality of life.

Time frame
At baseline and after three months of using rectal irrigation

Other outcomes

Sponsors and contacts

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