Informations générales (source: ClinicalTrials.gov)
Surgical Treatment of Large Incisional Hernia with Botulinum Toxin a Injection: a Double-blind Randomized Controlled Trial
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
janvier 2025
mars 2029
13 septembre 2025
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 is a significant risk factor for repair failure and
recurrence. High rates of severe postoperative morbidity, up to 50%, are reported, linked
to dissection extent, increased muscular tension, and abdominal pressure. Reconstructing
normal anatomy by bringing muscles together may be impossible, leading to the use of
complex procedures like component separation techniques (CST), involving large
aponeurotomy for muscle relaxation. Intramuscular injection of botulinum toxin A (BTA)
induces reversible flaccid paralysis, with potential benefits in hernia closure, known as
"chemical CST." Retrospective studies suggest reduced muscle retraction and facilitated
closure without specific morbidity. Prehabilitation with BTA aims to reduce surgical
morbidity compared to repair and CST. The prospective evaluation of BTA's clinical
benefits, including reduced postoperative morbidity, pain, successful abdominal closure,
and decreased IH recurrence risk, is lacking. A prospective randomized double-blind
placebo-controlled trial is proposed to demonstrate BTA's efficacy. The hypothesis is
that BTA injection before IH repair is more effective than a placebo in reducing
postoperative morbimortality. Secondary expectations include a significant reduction in
complete closure of the abdominal wall without CST.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HIA BEGIN | MOSZKOWICZ David | 13/12/2025 07:37:32 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 13/12/2025 07:37:32 | Contacter | |||
| AP-HP - Hôpital Avicenne | |||||
| AP-HP - Hôpital Louis Mourier | |||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| David Moszkowicz - Colombes - France | David Moszkowicz, Pr | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
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.
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.