Status:
RECRUITING
Surgery with Botulinum Toxin a for Incisional Hernia
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Incisional Hernia
Eligibility:
All Genders
18-79 years
Phase:
PHASE3
Brief Summary
After laparotomy, treating large incisional hernias (width \>= 10cm) proves challenging due to the progressive retraction of lateral abdominal muscles and the separation of rectus muscles. This width ...
Detailed Description
Almost 20% of patients will develop an incisional hernia (IH) after laparotomy. Each year in France, around 30,000 patients undergo IH repair with mesh \[PMSI, 2017\]. The treatment of large IH (width...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Other types of IH (lateral, groin, para-stomal, portsite);
- VHWG grades 3 or 4 for the risk of surgical site infection;
- 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;
- Severe hemostasis disorder or non-weaning treatment with curative dose anticoagulant;
- 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);
- 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;
- Patients with a history of seizures.
Key Trial Info
Start Date :
January 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 4 2029
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT06499324
Start Date
January 17 2025
End Date
March 4 2029
Last Update
January 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
David Moszkowicz
Colombes, France, France