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NCT Number: 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

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.

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Key information

Conditions

Fecal Incontinence Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Angers, Angers, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

injection into the intersphincter space

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

Other

injection into the intersphincter space

Primary outcomes

Number of fecal incontinence events

Time frame: 3 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ganivet Anne

CONTACT

[email protected]

02 99 28 25 55

Mevel Nicolas

CONTACT

[email protected]

02 99 28 25 55

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study 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

Acronym: AUTOGRAFI

Important dates

Study start: 2022
Primary completion: 2026
Study completion: 2027
First posted: Jul 22, 2021
Registry last updated: Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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