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

NCT04972799 | Recruiting

• 2 other identifiers: 35RC19_9798_AUTOGRAFI2020-A01890-39
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Fecal Incontinence

Keywords

Autograft

Outcome Measures

Primary Outcomes (1)

• Number of fecal incontinence events

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

  3 months

Study Arms (2)

Treatment/Placebo

EXPERIMENTAL

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

Placebo/Treatment

EXPERIMENTAL

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

Interventions

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

injection into the intersphincter space

Treatment/Placebo

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

injection into the intersphincter space

Placebo/Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (3)

CHU Angers

Angers, France

NOT YET RECRUITING

CHU Nantes

Nantes, France

NOT YET RECRUITING

CHU Rennes

Rennes, France

RECRUITING

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Brochard Charlène

  CHU Rennes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 22, 2021
• Study Start: October 19, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)