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

• Sponsor: Rennes University Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04972799
• Collaborator: (none)
• Enrollment: 50
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 66
• Patients Per Site: 16.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fecal Incontinence	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	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Oct 1, 2021
• Anticipated Primary Completion Date: Jan 1, 2022
• Anticipated Study Completion Date: Apr 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment/Placebo 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; injection into the intersphincter space
Experimental: Placebo/Treatment 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; injection into the intersphincter space

Outcome Measures

Primary Outcome Measures

1. Number of fecal incontinence events [3 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Angers	Angers		France
2	CHU Nantes	Nantes		France
3	CHU Rennes	Rennes		France

Sponsors and Collaborators

• Rennes University Hospital

Investigators

• Principal Investigator: Brochard Charlène, CHU Rennes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rennes University Hospital
• ClinicalTrials.gov Identifier: NCT04972799
• Other Study ID Numbers: 35RC19_9798_AUTOGRAFI; 2020-A01890-39
• First Posted: Jul 22, 2021
• Last Update Posted: Jul 22, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Rennes University Hospital: Autograft
• Additional relevant MeSH terms: Fecal Incontinence

Study Results

No Results Posted as of Jul 22, 2021