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

Fecal Incontinence Clinical Trial

— AUTOGRAFI  

Official title:

AUTOGRAFI : 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04972799
• Other study ID #: 35RC19_9798_AUTOGRAFI
• Secondary ID: 2020-A01890-39
• Status: Recruiting
• Phase: N/A
• Start date: October 19, 2022
• Est. completion date: November 2027

Study information

• Verified date: February 2023
• Source: Rennes University Hospital
• Contact: Mevel Nicolas
• Phone: 02 99 28 25 55
• Email: dri[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 2027
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CHU Nantes	Nantes
France	CHU Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of fecal incontinence events	Change from baseline in number of fecal incontinence events at 3 months	3 months