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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 (AUTOGRAFI)

Primary Purpose

Fecal Incontinence

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

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

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

About this trial

This is an interventional treatment trial for Fecal Incontinence focused on measuring Autograft

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU Angers
CHU Nantes
CHU RennesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Treatment/Placebo

Placebo/Treatment

Arm Description

treatment sequence at day 0 and placebo sequence at 6 months

placebo sequence at day 0 and treatment sequence at 6 months

Outcomes

Primary Outcome Measures

Number of fecal incontinence events

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04972799

First Posted

July 12, 2021

Last Updated

February 28, 2023

Sponsor

Rennes University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04972799

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 19, 2022 (Actual)

Primary Completion Date

November 2026 (Anticipated)

Study Completion Date

November 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rennes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fecal Incontinence

Keywords

Autograft

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment/Placebo

Arm Type

Experimental

Arm Description

treatment sequence at day 0 and placebo sequence at 6 months

Arm Title

Placebo/Treatment

Arm Type

Experimental

Arm Description

placebo sequence at day 0 and treatment sequence at 6 months

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

injection into the intersphincter space

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

injection into the intersphincter space

Primary Outcome Measure Information:

Title

Number of fecal incontinence events

Description

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

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mevel Nicolas

Phone

02 99 28 25 55

dri@chu-rennes.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Ganivet Anne

Phone

02 99 28 25 55

anne.ganivet@chu-rennes.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brochard Charlène

Organizational Affiliation

CHU Rennes

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Angers

City

Angers

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vénara Aurélien

Facility Name

CHU Nantes

City

Nantes

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Emilie Duchalais

Facility Name

CHU Rennes

City

Rennes

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brochard Charlène

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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