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Surgical treatment of large incisional hernia with botulinum toxin A injection: a double-blind randomized controlled trial
EU CTIS ID: 2023-504554-35-00
What this study is testing
To demonstrate that preoperative BTA injection in the lateral abdominal wall muscles reduces the rate of postoperative morbi-mortality after large IH (width ≥ 10cm) repair with mesh, compared with placebo injection.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Other types of IH (lateral, groin, para-stomal, port-site) are allowed, provided they are not the target of surgical treatment (i.e., not intended to be repaired as part of the current intervention)
- 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
See the full eligibility criteria
- 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) are allowed, provided they are not the target of surgical treatment (i.e., not intended to be repaired as part of the current intervention)
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.