NCT04972799 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
| NCT ID | NCT04972799 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rennes University Hospital |
| Condition | Fecal Incontinence |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2022-10-19 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2022-10-19 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Brochard Charlène
PRINCIPAL INVESTIGATOR
Rennes University Hospital
Frequently Asked Questions
Who can join the NCT04972799 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fecal Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04972799 currently recruiting?
Yes, NCT04972799 is actively recruiting participants. Contact the research team at dri@chu-rennes.fr for enrollment information.
Where is the NCT04972799 trial being conducted?
This trial is being conducted at Angers, France, Nantes, France, Rennes, France.
Who is sponsoring the NCT04972799 clinical trial?
NCT04972799 is sponsored by Rennes University Hospital. The principal investigator is Brochard Charlène at Rennes University Hospital. The trial plans to enroll 50 participants.