RecruitingNAINTERVENTIONAL

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

The 'ReVo Study' is looking at two types of rectal irrigation – a treatment where warm water is gently put into the back passage to help you go to the toilet. This treatment is often suggested for people with ongoing constipation that hasn't improved with other methods like diet changes or laxatives. The study wants to compare a 'low-volume' irrigation with a 'high-volume' irrigation to see which works best. Researchers want to know if one type is more effective, easier to use, and if certain people benefit more from one type over the other. The goal is to improve how people manage their chronic constipation and their quality of life.

At a glance

Status

Recruiting

Phase

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Enrolment target

166

Start

10 May 2024

Estimated completion

01 Jul 2025

Constipation - Functional Constipation Constipation by Outlet Obstruction Defecation Disorder

What is this study about?

If you have long-term constipation, you know how frustrating and uncomfortable it can be. Doctors sometimes suggest a treatment called 'rectal irrigation' when other options like lifestyle changes, laxatives, or special exercises haven't worked well enough. Rectal irrigation involves gently introducing warm tap water into the back passage (rectum) to help you empty your bowels. It's a way to help your body manage constipation when it struggles on its own.

There are two main ways this treatment is given: using a 'low volume' of water or a 'high volume' of water. Currently, we don't know if one method is better than the other, or if one works particularly well for people with specific types of constipation problems. This study, called The ReVo Study, aims to answer these very questions. By comparing the two types of irrigation, researchers hope to find out which one is more helpful, easier for people to use, and ultimately, which one gives the best results.

The main goal is to improve the lives of people with chronic constipation, especially those who have difficulty emptying their bowels. The study will look at how the different irrigation methods affect your quality of life, how well they help with symptoms, and whether your specific bowel problem (which will be checked using a special ultrasound) means one method is better for you. By taking part, you could help doctors understand how to give the best advice and treatment to future patients.

Key takeaways

Compares two types of rectal irrigation for chronic constipation.
Aims to find out which irrigation method (low-volume or high-volume) works best.
Looks at how irrigation impacts quality of life and symptom relief.
Includes a pelvic floor ultrasound to understand your specific bowel issue.
Participation involves 3 months of home use and one follow-up.
You'll be randomly assigned to one of the two irrigation groups.

Who may be eligible?

This study is looking for adults aged 18 or older who have been struggling with problematic constipation for at least six months. Your constipation should be linked to difficulty emptying your bowels, and you should have already tried and found that other treatments like laxatives, diet changes, and special bowel retraining haven't fully helped.

To join, you or someone helping you must be able to use the rectal irrigation equipment safely. You'll also need to be able to understand and agree to take part in the study.

You won't be able to join if you've had major bowel or pelvic surgery in the last three months, are pregnant, have ongoing rectal bleeding, suffered from certain serious bowel conditions (like cancer, complicated diverticular disease, or inflammatory bowel disease), are having chemotherapy, or have used rectal irrigation in the past year.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you had problematic constipation for at least 6 months, mostly with difficulty emptying your bowels?
Have you already tried laxatives, diet changes, and bowel retraining without enough success?
Are you able or do you have someone to help you use rectal irrigation equipment?
Have you NOT had major bowel or pelvic surgery in the last 3 months?
Have you NOT used rectal irrigation in the past year?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, your journey will start with a baseline assessment. This includes filling out four questionnaires about your quality of life and having a clinical examination. You'll also have a special ultrasound scan of your pelvic floor to help understand the cause of your symptoms. After this, you'll be randomly assigned to either the low-volume or high-volume rectal irrigation group, like tossing a coin – you'll have a 50/50 chance of being in either.

You'll receive training on how to use the irrigation system you've been assigned. Then, you'll start using it at home from the very next day. You'll continue to use the irrigation regularly for three months. After these three months, you'll have a follow-up appointment where you'll fill out the same quality-of-life questionnaires again. This information will help the researchers understand if your symptoms have improved. Your involvement in the study will finish after this three-month follow-up.

Potential risks and benefits

Taking part in this study could potentially improve your constipation symptoms and your overall quality of life, especially if other treatments haven't worked. You would also be contributing valuable information that could help many other people with similar problems in the future. As with any medical procedure, there's always a small chance of side effects or discomfort, though rectal irrigation is generally considered safe. The study design aims to carefully monitor your progress and well-being. It's important to remember that participating is entirely your choice, and you are free to withdraw from the study at any time without explaining why, and this will not affect your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

St Thomas' Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is rectal irrigation?

It's a treatment where warm water is gently introduced into your back passage (rectum) to help you empty your bowels, often used for long-term constipation.

What's the difference between low-volume and high-volume?

These refer to the amount of warm water used during the irrigation session. The study will compare these two different amounts.

Will I get to choose which type of irrigation I use?

No, you will be randomly assigned to either the low-volume or high-volume group. It's like flipping a coin to decide.

How long will I be in the study?

You'll be actively involved for three months, using the irrigation at home and having a follow-up assessment at the end of that period.

What if the irrigation doesn't work for me?

Your participation is voluntary, and you can stop using the irrigation and leave the study at any time if you feel it's not helping or if you have concerns.

How to find out more

Tanzeela Gala, FCPS-Surgery

tanzeela.gala@gstt.nhs.uk 07496288119 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.