Surgery with Botulinum Toxin a for Incisional Hernia

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jul 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medicine called botulinum toxin A (BTA) to help patients with large incisional hernias, which are bulges that can occur after abdominal surgery. The trial aims to see if injecting BTA before surgery can make it easier to close the hernia, reduce pain, and lower the chances of complications after the surgery. Researchers believe that BTA can help relax the muscles around the hernia, making it easier for doctors to repair it without needing more complicated procedures.

To participate in this trial, you need to be between 18 and 79 years old, have a body mass index (BMI) under 35, and have a specific type of hernia that is 10 cm or wider. You should also be scheduled for surgery to repair the hernia. If you join the trial, you will receive either the BTA injection or a placebo (a harmless substance) before your surgery, and you will be monitored for any changes in your recovery. The trial is currently recruiting, and participants will contribute to important research that could improve surgical outcomes for many people with incisional hernias.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients between 18 and 79 years;
• • 2. BMI \< 35 kg/m²;
• • 3. 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);
• • 4. 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;
• • 5. Written informed consent;
• • 6. Scheduled surgery for an open IH repair;
• • 7. For female of childbearing potential: using highly effective contraception.
• Exclusion Criteria:
• • 1. Other types of IH (lateral, groin, para-stomal, portsite);
• • 2. VHWG grades 3 or 4 for the risk of surgical site infection;
• • 3. Ongoing skin infection or inflammation at the IH site or at the BTA injection site;
• • 4. Planned IH repair with slowly absorbable mesh;
• • 5. IH with loss of domain (volumetric ratio \> 25%);
• • 6. Emergency IH surgery;
• • 7. ASA score \> 3;
• • 8. Pregnancy or breastfeeding;
• • 9. Ongoing treatment with aminoglycosides;
• • 10. Severe hemostasis disorder or non-weaning treatment with curative dose anticoagulant;
• • 11. Active tobacco use (or cessation inferior to 3 months);
• • 12. 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;
• • 13. Patient not covered by social insurance;
• • 14. Patient under legal guardianship;
• • 15. Hypersensitivity to the active substance (Clostridium Botulinum neurotoxin type A) or to any of the excipients (Human albumin, sucrose);
• • 16. 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);
• • 17. 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;
• • 18. Patient with severe and uncontrolled cardiovascular diseases;
• • 19. Patient has received BTA within 12 weeks;
• • 20. Patients with a history of seizures.