RecruitingNAINTERVENTIONAL

Evaluation of the Efficacy and Safety of Autologous Fat Injection Into the Intersphincter Space in Fecal Incontinence: a Randomized, Placebo-controlled, Cross-over, Double-blind Trial

This study is investigating a new way to treat faecal incontinence, also known as poop leaks. Many people suffer from this condition, and current treatments don't always work for everyone. In this trial, doctors will inject a small amount of a person's own fat (taken from another part of their body) into the area around the anal muscles. The aim is to see if this helps strengthen the muscles and reduce leaks. This treatment has been used successfully in plastic surgery. We want to find out if it is safe and effective for faecal incontinence and if it can improve people's quality of life. Participants will receive either the fat injection or a salt water injection first, and then swap after six months.

At a glance

Status

Recruiting

Phase

Sponsor

Rennes University Hospital

Enrolment target

Start

19 Oct 2022

Estimated completion

01 Nov 2027

Fecal Incontinence

What is this study about?

Faecal incontinence, or poop leaks, is a common and distressing condition that significantly affects daily life. While there are existing treatments like diet changes, exercise, and nerve stimulation, these don't always work for everyone. When these options fail, people can be left with very few choices beyond using specific enemas or even needing a colostomy (a surgical procedure to divert waste outside the body).

This study is exploring a new approach using a person's own body fat. This idea stems from plastic surgery, where injecting a person's own fat has been used for other purposes. Early, small studies have suggested that using fat injections around the anal muscles might help improve control and reduce leaks. This trial aims to rigorously test this idea in a more robust way.

The main goal of this study is to see if injecting a person's own fat into the muscle area around the anus can reduce the number of faecal incontinence episodes in people who experience severe leaks because of weak anal muscles. We also want to find out if this treatment can improve the strength of these muscles, whether it’s a comfortable and safe procedure for patients, and if it ultimately leads to a better quality of life.

Key takeaways

Exploring using a person's own fat to treat poop leaks.
Aims to reduce accidents and improve life quality.
Participants will eventually receive both fat and salt water injections.
Neither you nor your doctor will know the first injection you receive.
Focuses on people for whom other treatments haven't worked.

Who may be eligible?

To join this study, you need to be 18 years or older and experience severe poop leaks (at least once a week). You should have already tried other treatments like special diets and exercises, and these haven't worked, or you can't have or don't want nerve stimulation treatment.

There are also some reasons why you might not be able to join. For instance, if you have certain medical conditions like Crohn's disease, severe bowel problems, or have had recent bowel surgery or radiation. You also can't take part if you're pregnant, breastfeeding, or already in another medical study.

It's important that you're able to come to all the follow-up appointments and give your free and informed consent to participate. If you're a woman who could get pregnant, you'll need to use effective contraception throughout the study.

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?
Do you experience severe poop leaks (at least once a week)?
Have you already tried diet changes, exercises, or can't have nerve stimulation?
Are you able to attend all follow-up appointments?
Are you NOT pregnant or breastfeeding, and not currently in another medical trial?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to one of two groups. In one group, you'll have an injection of your own fat on day one and then an injection of salt water six months later. In the other group, you'll have the salt water injection first, followed by the fat injection six months later. This is a "cross-over" study, meaning everyone will eventually receive the fat injection.

Both you and your doctors won't know which injection you're getting first, which helps to keep the results fair. You'll have regular check-ups and assessments to monitor your symptoms and how you're feeling. The total duration of your active participation in the study will last for at least 12 months, including follow-up appointments after your final injection.

Potential risks and benefits

Participating in this study might offer a potential benefit by improving your faecal incontinence and quality of life if the fat injection proves effective. However, it's important to remember that this is a research study, and there's no guarantee it will work for everyone. Potential risks are generally low, as we are using your own fat, but as with any medical procedure, there's a small chance of minor side effects like discomfort or bruising at the injection sites. All procedures carry some risk, which your doctor will explain in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

CHU Angers
Verified postcode
Angers, France· Not yet recruiting
CHU Nantes
Verified postcode
Nantes, France· Not yet recruiting
CHU Rennes
Verified postcode
Rennes, France· Recruiting

Common questions

What is faecal incontinence?

Faecal incontinence means having accidental leaks of solid or liquid poo, which can be upsetting and impact daily life.

What is 'autologous fat'?

'Autologous fat' simply means using your own body fat. It's taken from one part of your body (like the tummy) and injected into another.

Will I know if I'm getting fat or salt water first?

No, neither you nor your doctors will know which injection you're getting first. This is called 'double-blind' and helps ensure the study results are fair.

What if the first treatment I get doesn't work?

Everyone in the study will eventually receive the active fat injection, even if they start with the salt water injection. Your experience will be monitored throughout.

Is this a new treatment?

Using a person's own fat has been used in other areas of medicine, but its use for faecal incontinence is still being carefully studied to see how well and how safely it works.

How to find out more

Mevel Nicolas

dri@chu-rennes.fr 02 99 28 25 55 Official trial record

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