Prevention with Sublay Mesh of Trocar Site Hernia (PRESUME): Study Protocol for a Multicenter Randomized Controlled Trial.

Abstract

<h4>Background</h4>Trocar Site Incisional Hernia (TSIH) is the most common postoperative complication after laparoscopic surgery, with incidences exceeding 30% in high-risk patients. Despite advances in minimally invasive approaches, optimal preventive strategies remain uncertain, and evidence comparing closure or reinforcement techniques is limited. Prophylactic mesh use shows benefits in open surgery, but its role in laparoscopy requires further clarification.<h4>Objective</h4>The PRESUME study evaluates whether prophylactic sublay mesh placement at the umbilical trocar site reduces TSIH incidence in patients undergoing laparoscopic cholecystectomy who present at least one established risk factor. Secondary objectives include assessing mesh-related complications and short- and long-term postoperative outcomes.<h4>Methods</h4>This prospective, multicentre, randomised controlled trial provides Level I evidence. Eligible participants are adults scheduled for laparoscopic cholecystectomy with diabetes mellitus, BMI ≥30 kg/m², age ≥65 years, or requiring umbilical incision enlargement. Patients will be randomised 1:1 to standard aponeurotic closure or intraperitoneal sublay mesh reinforcement (Ventralex™ ST). Follow-up visits are scheduled at 30 days, 6 months, 1 year-with ultrasound-and 2 years. The principal investigator will remain blinded during follow-up. The primary endpoint is TSIH incidence; secondary outcomes include surgical site events, postoperative pain, readmissions, and time to return to daily activities. Based on expected TSIH reduction from 35% to 10%, 42 patients per arm are required.<h4>Discussion</h4>TSIH remains a significant postoperative issue with limited preventive evidence in laparoscopy. By assessing the efficacy and safety of prophylactic sublay mesh reinforcement, the PRESUME trial may support future recommendations and improve outcomes in high-risk patients.