Surgical Treatment of Large Incisional Hernia with Botulinum Toxin A Injection A Double-blind Randomized Controlled Trial Evaluating Preoperative Botulinum Toxin A for Hernia Repair

What this Trial Is About

Large incisional hernias (IH) with a width of 10 cm or more are difficult to repair due to muscle retraction and separation of abdominal muscles, leading to high failure and recurrence rates. This condition often results in severe postoperative complications, sometimes affecting up to half of patients. Traditional surgical methods may require complex techniques like component separation to relax muscles. Researchers are evaluating whether injecting botulinum toxin A (BTA) into the lateral abdominal muscles before surgery can reduce these risks by relaxing the muscles and improving hernia closure. Participants will receive either a BTA injection or a placebo injection into their lateral abdominal muscles 4 to 6 weeks before undergoing open surgical repair of their large incisional hernia with mesh. The BTA group receives 288 IU of BTA in 18 injection sites under ultrasound guidance, while the placebo group receives a matching volume of inert solution. Both treatments are administered during outpatient visits. The study is a prospective, randomized, double-blind, placebo-controlled trial designed to assess the effectiveness of BTA in reducing postoperative complications compared to placebo. During the study, participants will be monitored for 90 days after surgery to evaluate the rate of postoperative morbidity and mortality. Researchers will assess the success of abdominal wall closure, pain levels, and the risk of hernia recurrence. The study involves imaging with abdominal CT scans before inclusion to measure hernia size and volume. Safety and adverse events will be closely followed, with data collected on surgical outcomes and recovery. The total participation includes preoperative injection and postoperative follow-up over three months.

Surgery with Botulinum Toxin a for Incisional Hernia