Using Botulinum Toxin A to Improve Surgery for Large Incisional Hernias

Surgical Treatment of Large Incisional Hernia with Botulinum Toxin a Injection: a Double-blind Randomized Controlled Trial

This study is testing if injections of Botulinum Toxin A can help make surgery easier and more successful for people with large incisional hernias.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 260 (estimated)
• Ages: 18 Years to 79 Years
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (other)
• Locations: 1 site (Colombes, France)
• Trial ID: NCT06499324 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of Botulinum Toxin A (BTA) injections to facilitate the surgical repair of large incisional hernias, which are challenging to treat due to muscle retraction and separation. The study compares outcomes between patients receiving BTA and those receiving a placebo, aiming to reduce postoperative morbidity and improve surgical closure success. By inducing temporary muscle paralysis, BTA may help relax the abdominal muscles, making it easier to close the hernia without complex surgical techniques. The trial includes patients aged 18 to 79 with specific criteria related to hernia size and type.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 79 with a midline incisional hernia of at least 10 cm in width and without loss of domain.

Not a fit: Patients with other types of hernias, severe infection risks, or those requiring specific surgical techniques may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce surgical complications and improve recovery for patients with large incisional hernias.

How similar studies have performed: Retrospective studies have suggested that similar approaches using BTA for muscle relaxation have shown promise, indicating potential for success in this prospective trial.

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.

Where this trial is running

Colombes, France

• David Moszkowicz — Colombes, France, France (RECRUITING)

Study contacts

• Principal investigator: David MOSZKOWICZ — APHP
• Study coordinator: David MOSZKOWICZ, MD-PhD

Conditions: Incisional Hernia, Botulinum toxin A, Incisional Hernia repair, Laparatomy