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

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