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Preoperative BOTOX® Injection for Large Ventral Hernia Repair

RecruitingPhase 4Ages 18 Years - anyAllThe Cleveland Clinic
NCT07220382 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study is for adults who need open surgery to repair a very large abdominal (ventral) hernia. This study tests whether a one-time, image-guided injection of a medicine commonly known as "BOTOX®" (onabotulinumtoxinA) into the side abdominal muscles 3-7 weeks before surgery helps surgeons close the abdominal wall fully at the end of the operation. Closing the muscle and tissue layers ("primary fascial closure") is linked to fewer problems after surgery and better quality of life. Participants will be randomly assigned (like a coin flip) to receive either the BOTOX® medicine or a saltwater (placebo) injection. Neither patients nor the care team will know which one was given. All participants will still have their planned hernia repair in the standard way that we repair patients who are not part of the study. The study will track whether the abdomen can be closed without leaving a gap,

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📋 Eligibility rules (as published)
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
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What it tests

  • OnabotulinumtoxinA Injection
  • Saline (placebo) Injection
  • OnabotulinumtoxinA
  • 0.9 % Normal Saline
  • Open Ventral Hernia Repair
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Where

1 site
Cleveland Clinic Main Campus
Cleveland, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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