Actively Recruiting
Surgical Treatment of Large Incisional Hernia with Botulinum Toxin A Injection: A Double-blind Randomized Controlled Trial
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-01-22
260
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a new approach to repair large incisional hernias, defined as those 10 cm or wider, which are challenging to treat due to muscle retraction and separation. This condition often leads to high rates of surgical complications, pain, and hernia recurrence. The study aims to evaluate whether injecting botulinum toxin A (BTA) into the abdominal muscles before surgery can reduce these risks compared to a placebo. This trial is a phase 3, randomized, double-blind, placebo-controlled study assessing BTA's potential benefits in hernia repair outcomes. Participants will be divided into two groups. One group will receive 288 IU of BTA injected into the lateral abdominal muscles at 18 sites, performed 4 to 6 weeks before open hernia repair with mesh. The other group will receive a placebo injection following the same procedure. Both injections are given under ultrasound guidance during outpatient hospitalization. The study compares the effects of BTA injection versus placebo on surgical outcomes and muscle relaxation. During the study, participants will undergo preoperative CT scans and post-injection CT scans to assess muscle changes. Researchers will monitor surgical difficulty, postoperative complications, pain levels, analgesic use, hospital stay length, and hernia recurrence up to 12 months after surgery. Intra-abdominal pressure will be tracked until bladder catheter removal. Quality of life assessments will also be conducted at several points post-surgery. The trial duration includes a 90-day postoperative period for primary outcome evaluation and extended follow-up for secondary outcomes.
CONDITIONS
Brief Title
Surgery with Botulinum Toxin a for Incisional Hernia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients between 18 and 79 years old
- Body mass index (BMI) less than 35 kg/m²
- Midline anterior primary or recurrent incisional hernia with width 10 cm or more, confirmed by recent CT scan
- Hernia without loss of domain, defined by specific volume ratio under 25% on CT
- Signed informed consent
- Scheduled for open incisional hernia repair surgery
- For women of childbearing potential, use of highly effective contraception
You will not qualify if you...
- Presence of other hernia types such as lateral, groin, para-stomal, or portsite
- High risk of surgical site infection (VHWG grades 3 or 4)
- Current skin infection or inflammation at hernia or injection sites
- Planned repair with slowly absorbable mesh
- Hernia with loss of domain (volume ratio above 25%)
- Emergency hernia surgery
- ASA score greater than 3
- Pregnancy or breastfeeding
- Ongoing treatment with aminoglycosides
- Severe bleeding disorders or curative anticoagulant treatment
- Active tobacco use or cessation less than 3 months ago
- Use of other investigational products recently or participation in other trials
- Lack of social insurance coverage
- Under legal guardianship
- Allergy to botulinum toxin A or formulation ingredients
- General muscle disorders or neurological conditions affecting muscles
- Use of certain muscle relaxant medications
- Severe uncontrolled cardiovascular disease
- Previous botulinum toxin injection within 12 weeks
- History of seizures
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 to 6 weeks
Participants receive a blind injection of botulinum toxin A or placebo into the lateral abdominal muscles 4 to 6 weeks before surgery to relax the muscles and facilitate hernia repair.
1 outpatient visit for injection
Duration - Surgery day and immediate recovery
Participants undergo open incisional hernia repair with mesh after the injection period.
1 hospital stay (average 5 days)
Duration - Up to 12 months
Participants are monitored for surgical complications, pain management, and recovery up to 12 months after surgery.
Multiple visits including assessments on days 1 to 7 post-surgery and at 1, 3, 6, and 12 months
Trial Site Locations
Total: 1 location
1
David Moszkowicz
Colombes, France, France
Actively Recruiting
Research Team
D
David MOSZKOWICZ, MD-PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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