Surgical Repair of Large Incisional Hernia Using Botulinum Toxin A Injection A Phase 3 Double-Blind Randomized Trial

What this Trial Is About

Researchers are investigating a new approach to repair large incisional hernias, defined as those 10 cm or wider, which are challenging to treat due to muscle retraction and separation. This condition often leads to high rates of surgical complications, pain, and hernia recurrence. The study aims to evaluate whether injecting botulinum toxin A BTA into the abdominal muscles before surgery can reduce these risks compared to a placebo. This trial is a phase 3, randomized, double-blind, placebo-controlled study assessing BTAs potential benefits in hernia repair outcomes. Participants will be divided into two groups. One group will receive 288 IU of BTA injected into the lateral abdominal muscles at 18 sites, performed 4 to 6 weeks before open hernia repair with mesh. The other group will receive a placebo injection following the same procedure. Both injections are given under ultrasound guidance during outpatient hospitalization. The study compares the effects of BTA injection versus placebo on surgical outcomes and muscle relaxation. During the study, participants will undergo preoperative CT scans and post-injection CT scans to assess muscle changes. Researchers will monitor surgical difficulty, postoperative complications, pain levels, analgesic use, hospital stay length, and hernia recurrence up to 12 months after surgery. Intra-abdominal pressure will be tracked until bladder catheter removal. Quality of life assessments will also be conducted at several points post-surgery. The trial duration includes a 90-day postoperative period for primary outcome evaluation and extended follow-up for secondary outcomes.

Surgery with Botulinum Toxin a for Incisional Hernia