Preoperative BOTOX® Injection for Large Ventral Hernia Repair

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Hernia Abdominal Wall, Botox Injection, Hernia Incisional Ventral, Hernia Repair With Compartment Syndrome, Hernia Surgery, Hernia, Hernia Incisional

In brief

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, and investigators will also look at recovery, complications, time in the ICU or on a ventilator, length of stay, pain, and quality-of-life scores. Most information will be collected during participants' hospital stay, but the investigators will continue to see how participants are doing up to 2 years after surgery. Short phone check-ins will occur before surgery, and after surgery follow-up happens around 30 days, 90 days, 1 year, and 2 years. Possible risks from the injection include temporary muscle weakness, trouble swallowing or breathing, pain or infection at the injection site, and (if CT is used for guidance) a small amount of radiation exposure. Surgery itself carries the usual risks (pain, bleeding, wound problems). Benefits are not guaranteed, but the injection may make closure easier and recovery smoother. About 188 people will take part at Cleveland Clinic.

Key facts

Study ID: NCT07220382
Run by: The Cleveland Clinic
People needed: 188
Starts: 2025-11-03
Expected to finish: 2029-12-15
Last updated by the study team: 2025-11-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 is running

Cleveland Clinic Main Campus — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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