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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

RecruitingNAAges 18 Years - anyAllRennes University Hospital
NCT04972799 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Fecal incontinence is frequent and has a significant impact on the quality of life of individuals. Its therapeutic management is based primarily on transit regulation and rehabilitation and secondarily on neuromodulation of the sacral roots. However, this strategy is insufficient in more than one patient out of three. The patient and the clinician are often at a loss and the therapeutic possibilities are limited to the use of evacuating enemas and/or a colostomy. The practice of autologous fat injections was initially developed in plastic surgery. The studies that have evaluated the efficacy of autologous fat injections in fecal incontinence in men are preliminary and old isolated observations. However, they have shown an improvement in episodes of fecal incontinence and in sphincter parameters. In the field of proctology and autologous fat injections, 2 recent small open studies have e

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📋 Eligibility rules (as published)
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
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What it tests

  • injection of autologous fat at Day 0 and injection of saline at 6 months
  • injection of saline at Day 0 and injection of autologous fat at 6 months
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Where

3 sites
CHU Angers
Angers, France
CHU Nantes
Nantes, France
CHU Rennes
Rennes, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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