Surgery with Botulinum Toxin a for Incisional Hernia
Recruiting
Phase 3
Interventional Study
Incisional Hernia
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 79
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 260 (estimated)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Other
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About This Trial
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 abdo…
Trial Locations
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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…
Contacts