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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A01890-39 | Other Identifier | N° IDRCB |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment/Placebo | Experimental | treatment sequence at day 0 and placebo sequence at 6 months |
|
| Placebo/Treatment | Experimental | placebo sequence at day 0 and treatment sequence at 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| injection of autologous fat at Day 0 and injection of saline at 6 months | Other | injection into the intersphincter space |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of fecal incontinence events | Change from baseline in number of fecal incontinence events at 3 months | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mevel Nicolas | Contact | 02 99 28 25 55 | dri@chu-rennes.fr | |
| Ganivet Anne | Contact | 02 99 28 25 55 | anne.ganivet@chu-rennes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Brochard Charlène | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Not yet recruiting | Angers | France |
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| injection of saline at Day 0 and injection of autologous fat at 6 months | Other | injection into the intersphincter space |
|
| CHU Nantes | Not yet recruiting | Nantes | France |
|
| CHU Rennes | Recruiting | Rennes | France |
|
| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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