Pre-surgery BOTOX to help close very large ventral hernias
Official title: PREoperative Targeted OnabotulinumtoXina Injection for Abdominal Wall Reconstruction: A Randomized, Double-Blind, Placebo-Controlled Trial
Run by The Cleveland Clinic · NCT07220382 · Data updated 2026-11-12
This test tries a one-time image-guided BOTOX injection into the side abdominal muscles 3–7 weeks before open repair to see if it helps surgeons fully close very large ventral hernias in adults.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 188 (estimated) |
| Sponsor | The Cleveland Clinic Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Cleveland, Ohio) |
| Status | Recruiting |
| Started | November 3, 2025 |
| Main results expected | December 15, 2027 |
| Study ends | December 15, 2029 |
| Registry record updated | October 26, 2026 |
| Trial ID | NCT07220382 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) scheduled for elective open midline repair of a very large ventral hernia (defect width ≥15 cm or Tanaka volume ratio ≥25%) who can attend the preoperative injection 3–7 weeks before surgery are ideal candidates.
✕Probably not a fit
Patients having emergent repairs, pregnancy or breastfeeding, known neuromuscular disorders, existing stomas, active infection at injection site, allergy to botulinum toxin or local anesthetic, or inability to attend the outpatient injection schedule are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, double-blind, placebo-controlled trial enrolls adults with very large ventral hernias who are scheduled for elective open midline repair. Participants are randomly assigned to receive a single image-guided onabotulinumtoxinA (BOTOX®) injection or a saline placebo 3–7 weeks before surgery, with both patients and care teams blinded. The main outcome is whether the abdominal wall can be closed without a gap (primary fascial closure); secondary outcomes include complications, ICU or ventilator use, pain, and hospital length of stay. Analyses are primarily intention-to-treat, with a per-protocol supplement and a single planned interim analysis at 50% of primary endpoint completion.
Why it matters
Potential benefit: If successful, preoperative BOTOX could raise full-closure rates for very large ventral hernias and reduce complications, ICU time, and recovery burden.
How similar studies have gone: Retrospective and single-center series have suggested higher closure rates with preoperative onabotulinumtoxinA, but randomized controlled evidence is limited and this trial aims to provide definitive data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult (greater than or equal to 18 years of age) * Candidate for elective open repair of ventral hernia * Preoperative imaging demonstrating either: * ventral hernia defect width of at lest 15 cm; AND/OR, * Tanaka volume ratio of at least 25% * Planned elective hernia repair in an open fashion via a midline laparotomy with posterior component separation and transversus abdominis release Exclusion Criteria: * Emergent cases * Pregnancy and/or breastfeeding at time of intramuscular injection * Inability to provide informed consent * Inability to receive either study intervention (i.e. allergy to local anesthetics utilized for intervention administration, allergy and/or contraindication to any botulinum toxin, inability to attend outpatient administration of study intervention, inability to conform to safety check schedule) * Known congenital or acquired neuromuscular disorder * Presence of stoma * Current infection at time of intramuscular injection * Flank hernias s defined by EHS L1-L4 * BMI \> 45 kg/m\^2 * Diaphragmatic hemiparesis or chronic obstructive pulmonary disease (COPD) with chronic oxygen dependence
Where it's running
-
Cleveland Clinic Main Campus
Cleveland, Ohio, United States Recruiting
Study contacts
- Principal investigator: Lucas R Beffa, MD — The Cleveland Clinic
- Study coordinator: Lucas R Beffa, MD
- Email: beffal@ccf.org
- Phone: 216-445-5975
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.