Surgical treatment of large incisional hernia with botulinum toxin A injection: a double-blind randomized controlled trial
- Conditions
- incisional herniaTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- CTIS2023-504554-35-00
- Lead Sponsor
- Assistance Publique Hopitaux De Paris
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 260
Patients between 18 and 79 years, BMI < 35 kg/m², Midline anterior primary or recurrent IH (subxiphoidal to suprapubic), of width >= 10 cm, on the abdominopelvic CT without injection of contrast agent, performed in the 6 months before inclusion (EHS W3), IH without loss of domain, defined by the ratio: (volume of the peritoneal sac) / (total peritoneal volume) < 25%, on the abdominal CT without injection of contrast agent, performed in the 6 months before inclusion, Written informed consent, Scheduled surgery for an open IH repair, For female of childbearing potential: using highly effective contraception
Other types of IH (lateral, groin, para-stomal, port-site), Ongoing skin infection or inflammation at the IH site or at the BTA injection site, Planned IH repair with slowly absorbable mesh, IH with loss of domain (volumetric ratio > 25%), Emergency IH surgery, ASA score > 3, Pregnancy or breastfeeding, Ongoing treatment with aminoglycosides, Patient with ongoing treatment with medicinal products that interfere with the transfer of an impulse from a nerve to a muscle, e.g. tubocurarine-type muscle relaxants that weaken the muscles, Patient with severe and uncontrolled cardiovascular diseases, Patient has received BTA within 12 weeks, Severe hemostasis disorder or non-weaning treatment with curative dose anticoagulant, Patients with a history of seizures, Active tobacco use (or cessation inferior to 3 months), Use of another investigational product within 6 months or 5 half-lives (whichever is longer), or currently participating in a prospective study with an investigational product, whether it concerns an experimental drug or a medical device, Patient not covered by social insurance, Patient under legal guardianship, Hypersensitivity to the active substance (Clostridium Botulinum neurotoxin type A) or to any of the excipients (Human albumin, sucrose), Generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome), peripheral motor neuropathic diseases (e.g. amyotrophic lateral sclerosis or motor neuropathy), facial nerve disorders, underlying neurological disorders) and history of dysphagia and aspiration), VHWG grades 3 or 4 for the risk of surgical site infection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method