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Clinical Trials in France / NCT04972799
Recruiting Not applicable

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

NCT04972799 · tracked via the Priya Life Science France tracker
Sponsor
Rennes University Hospital
Phase
Not applicable
Started
2022-10-19
Last updated
2024-09-25

Condition(s) studied

Fecal Incontinence

Investigational drug(s) / intervention(s)

injection of autologous fat at Day 0 and injection of saline at 6 monthsinjection of saline at Day 0 and injection of autologous fat at 6 months

injection of autologous fat at Day 0 and injection of saline at 6 months: injection into the intersphincter space

injection of saline at Day 0 and injection of autologous fat at 6 months: injection into the intersphincter space

Study summary

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 evaluated the efficacy and morbidity of this therapy in the treatment of anal fistulas related to Crohn's disease.

The primary hypothesis of the work is that autografting adipose tissue into the intersphincteric space can decrease episodes of fecal incontinence in patients with severe fecal incontinence due to sphincter failure. The secondary hypotheses are that autograft of adipose tissue in the intersphincter space improves resting anal pressures, is a well-tolerated technique for patients, and may improve their quality of life.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Number of fecal incontinence events — 3 months
    Change from baseline in number of fecal incontinence events at 3 months

Trial sites (3)

FacilityCityRegionStatus
CHU Angers Angers France Not Yet Recruiting
CHU Nantes Nantes France Not Yet Recruiting
CHU Rennes Rennes France Recruiting

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Other trials for the same condition

Mechanisms of Action on Rectal Motricity of Intrarectal Botulinum Toxin Injections Recruiting
Skeletal Muscle-derived Cell Implantation for Treatment of Fecal Incontinence Recruiting
Mechanisms of Fecal Incontinence in Wolfram Syndrome Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04972799 on ClinicalTrials.gov ↗ ← All trials in France