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

Launched by RENNES UNIVERSITY HOSPITAL · Jul 21, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for people suffering from severe fecal incontinence, a condition that can greatly affect quality of life. The researchers are looking at whether injecting a patient's own fat into a specific area between the anal sphincter muscles can help reduce the number of incontinence episodes. This method is based on previous studies that suggest fat injections might improve the condition. Participants in this trial must be at least 18 years old, have experienced severe fecal incontinence despite trying other treatments, and be willing to follow up with the study.

If you decide to participate, you will receive either the fat injection or a placebo (a treatment that doesn't have an active effect) in a random order, ensuring that neither you nor the researchers know which treatment you received at first. The goal is to see if this new approach not only decreases incontinence episodes but also improves your overall quality of life and comfort. It's important to note that certain medical conditions, previous surgeries, and other factors may prevent someone from being eligible for the study.

Gender

ALL

Eligibility criteria

• 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