Randomized Trial of Preoperative BOTOX Injection to Improve Closure in Large Ventral Hernia Surgery

What this Trial Is About

This research aims to evaluate whether a one-time, image-guided injection of onabotulinumtoxinA commonly known as BOTOX4 into the side abdominal muscles before surgery can help adults needing open surgery to repair very large abdominal ventral hernias. The study compares BOTOX4 injections with placebo saline injections to see if this approach improves the ability to fully close the abdominal wall during surgery, which is linked to fewer complications and better quality of life. This is a randomized, double-blind, placebo-controlled trial conducted at a single center. Participants will be randomly assigned to receive either BOTOX4 or a saline placebo injection at six sites on the lateral abdominal wall, 21 to 48 days before their scheduled open ventral hernia repair surgery. Each injection involves a total of 300 units of onabotulinumtoxinA or an equal volume of saline, given under ultrasound or radiographic guidance. All participants will undergo standard hernia repair surgery, with surgeons unaware of the treatment group. Throughout the study, participants will be closely monitored during their hospital stay and followed for up to two years after surgery. Assessments include whether the hernia can be closed fully at the end of surgery, recovery progress, complications, time in intensive care and on ventilators, length of hospital stay, pain levels, and quality of life surveys. Follow-up visits or phone checks occur before surgery and at 30 days, 90 days, 1 year, and 2 years post-surgery to gather detailed outcome data.

Preoperative BOTOX® Injection for Large Ventral Hernia Repair