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

Study Overview
=================
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.

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

Conditions
-----------------
Fecal Incontinence

Intervention / Treatment
-----------------
* Other: injection of autologous fat at Day 0 and injection of saline at 6 months
* Other: injection of saline at Day 0 and injection of autologous fat at 6 months


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older severe fecal incontinence characterized by at least one episode of weekly fecal incontinence failed rehabilitation and dietary management strategies who have failed/contraindicated/refused sacral root neuromodulation (in the indication of fecal incontinence) having, for women of childbearing age, effective contraception throughout the study having given free, informed and written consent Exclusion Criteria: unable or unwilling to undergo follow-up or symptomatic evaluation contraindication to general anesthesia contraindication to metronidazole (hypersensitivity and wheat allergy) significant pelvic static disorder active anal suppuration anal stenosis externalized rectal prolapse chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis) on anticoagulants or antiaggregants history of anal or rectal neoplasia coagulation anomaly, curative anticoagulation history of rectal surgery history of pelvic radiotherapy previous treatment with inert materials (hyaluronic acid, biosilicones, coaptitis) in the 5 years preceding inclusion allergy to lidocaine or contraindication to adrenaline protected person (adult subject to legal protection (safeguard of justice, curatorship, guardianship), person deprived of liberty, pregnant or breast-feeding woman, minor) participating in another interventional trial concurrently not covered by a social security system

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment/Placebo<br>treatment sequence at day 0 and placebo sequence at 6 months | Other: injection of autologous fat at Day 0 and injection of saline at 6 months<br>* injection into the intersphincter space<br>|
| Experimental: Placebo/Treatment<br>placebo sequence at day 0 and treatment sequence at 6 months | Other: injection of saline at Day 0 and injection of autologous fat at 6 months<br>* injection into the intersphincter space<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of fecal incontinence events | Change from baseline in number of fecal incontinence events at 3 months | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autograft