Status:
RECRUITING
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
Joseph and Florence Mandel Family Foundation
Conditions:
Hernia Abdominal Wall
Botox Injection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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®" (...
Detailed Description
Background and Rationale: Massive ventral hernias (pre-op axial width ≥15 cm and/or Tanaka volume ratio \>25%) seldom achieve primary fascial closure (PFC) and are associated with higher respiratory ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2029
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT07220382
Start Date
November 3 2025
End Date
December 15 2029
Last Update
November 21 2025
Active Locations (1)
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1
Cleveland Clinic Main Campus
Cleveland, Ohio, United States, 44195