Using fat injections to treat fecal incontinence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of injecting autologous fat into the intersphincter space for patients suffering from severe fecal incontinence. Participants will receive either the fat injection or a saline placebo in a randomized, double-blind, crossover design, allowing for direct comparison of outcomes. The study aims to address the limitations of current treatment options, particularly for those who have not responded to rehabilitation or neuromodulation therapies. By assessing the impact on fecal incontinence episodes and sphincter function, the trial seeks to provide new therapeutic insights.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 18 years of age or older
2. severe fecal incontinence characterized by at least one episode of weekly fecal incontinence
3. failed rehabilitation and dietary management strategies
4. who have failed/contraindicated/refused sacral root neuromodulation (in the indication of fecal incontinence)
5. having, for women of childbearing age, effective contraception throughout the study
6. having given free, informed and written consent

Exclusion Criteria:

1. unable or unwilling to undergo follow-up or symptomatic evaluation
2. contraindication to general anesthesia
3. contraindication to metronidazole (hypersensitivity and wheat allergy)
4. significant pelvic static disorder
5. active anal suppuration
6. anal stenosis
7. externalized rectal prolapse
8. chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis)
9. on anticoagulants or antiaggregants
10. history of anal or rectal neoplasia
11. coagulation anomaly, curative anticoagulation
12. history of rectal surgery
13. history of pelvic radiotherapy
14. previous treatment with inert materials (hyaluronic acid, biosilicones, coaptitis) in the 5 years preceding inclusion
15. allergy to lidocaine or contraindication to adrenaline
16. protected person (adult subject to legal protection (safeguard of justice, curatorship, guardianship), person deprived of liberty, pregnant or breast-feeding woman, minor)
17. participating in another interventional trial concurrently
18. not covered by a social security system

Where it's running

• CHU Rennes
  Rennes, France Recruiting
• CHU Angers
  Angers, France Not yet recruiting
• CHU Nantes
  Nantes, France Not yet recruiting

Study contacts

• Principal investigator: Brochard Charlène — Rennes University Hospital
• Study coordinator: Mevel Nicolas
• Email: dri@chu-rennes.fr
• Phone: 02 99 28 25 55

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Investigating the effects of sacral neuromodulation on fecal incontinence and the external anal sphincter

  This study is trying to see how a treatment called sacral neuromodulation can help people with fecal incontinence by looking at changes in the muscles around the anus.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.