Fecal IncontinenceAUTOGRAFINCT04972799
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
A study testing injection of autologous fat at Day 0 and injection of saline at 6 months and injection of saline at Day 0 and injection of autologous fat at 6 months in people with Fecal Incontinence, run by Rennes University Hospital at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- injection of autologous fat at Day 0 and injection of saline at 6 months and injection of saline at Day 0 and injection of autologous fat at 6 months
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesFrance
- Study dates
- 19 Oct 2022to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Not yet recruiting
CHU Angers
Angers
Vénara Aurélien
- Not yet recruiting
CHU Nantes
Nantes
Emilie Duchalais
- Recruiting
CHU Rennes
Rennes
Brochard Charlène
About this study
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
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.
- Conditions
- Fecal Incontinence
- Being tested
- 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
- Keywords
- Autograft
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection of autologous fat at Day 0 and injection of saline at 6 monthsOther
injection into the intersphincter space
injection of saline at Day 0 and injection of autologous fat at 6 monthsOther
injection into the intersphincter space
| Study group | Role | What they receive |
|---|---|---|
| Treatment/Placebo | Experimental | treatment sequence at day 0 and placebo sequence at 6 months Receives: Other: injection of autologous fat at Day 0 and injection of saline at 6 months |
| Placebo/Treatment | Experimental | placebo sequence at day 0 and treatment sequence at 6 months Receives: Other: injection of saline at Day 0 and injection of autologous fat at 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of fecal incontinence events
Change from baseline in number of fecal incontinence events at 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start19 Oct 2022
- Primary completionNov 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brochard Charlène, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972799
- Sponsor's protocol ID
- 35RC19_9798_AUTOGRAFI
- Other IDs
- 2020-A01890-39
- Acronym
- AUTOGRAFI
- Status last verified
- Sep 2024
- First submitted
- 12 Jul 2021
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04972799
- Acronym / sponsor ID
- AUTOGRAFI / 35RC19_9798_AUTOGRAFI
- Conditions
- Fecal Incontinence
- Keywords
- Autograft
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment/Placebo | Experimental | Other: injection of autologous fat at Day 0 and injection of saline at 6 monthstreatment sequence at day 0 and placebo sequence at 6 months |
| Placebo/Treatment | Experimental | Other: injection of saline at Day 0 and injection of autologous fat at 6 monthsplacebo sequence at day 0 and treatment sequence at 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| injection of autologous fat at Day 0 and injection of saline at 6 monthsinjection into the intersphincter space | Other | Treatment/Placebo |
| injection of saline at Day 0 and injection of autologous fat at 6 monthsinjection into the intersphincter space | Other | Placebo/Treatment |
Primary outcome
Number of fecal incontinence events
Time frame: 3 months
Change from baseline in number of fecal incontinence events at 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brochard Charlène principal investigator
Rennes University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing injection of autologous fat at Day 0 and injection of saline at 6 months and injection of saline at Day 0 and injection of autologous fat at 6 months in people with Fecal Incontinence, run by Rennes University Hospital at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mevel Nicolas (02 99 28 25 55, dri@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of fecal incontinence events (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.