Preventing Incisional Hernia After Laparoscopic Gallbladder Surgery Using Onlay Mesh at the Umbilical Trocar Site

What this Trial Is About

This research aims to evaluate the preventive effect of placing an onlay mesh compared to using a standard fascial closure device at the umbilical trocar site to prevent incisional hernia after laparoscopic surgery. The study focuses on adult patients undergoing elective laparoscopic cholecystectomy, with or without exploration of the common bile duct. The trial is a two-center randomized controlled study designed to address the high prevalence of incisional hernia after laparoscopy, which can be as high as 30%, and to improve closure techniques using imaging methods for accurate diagnosis. Participants will be randomly assigned to one of two groups. In the prosthesis group, after suturing the aponeurosis, a lightweight, large-pore mesh made of PVDF monofilament will be placed onlay over the incision and fixed with cyanoacrylate glue. In the control group, the aponeurosis will be closed using the standard suturing technique without mesh. Both procedures take place after the laparoscopic cholecystectomy is performed. Follow-up includes an abdominal ultrasound scan focused on aponeurosis defects at the trocar sites at 12 months post-surgery to detect hernia occurrence. During the study, adverse events will be monitored and classified according to the Clavien Dindo classification. Participants will be assessed with ultrasound imaging at 12 months to reduce underdiagnosis of incisional hernia. Data analysis will include statistical comparisons between groups to evaluate the effectiveness of the mesh in preventing hernias. The minimum follow-up period is 12 months, and economic impact and perioperative complications within 30 days will also be reviewed.

Trocar Site Incisional Hernia Prevention