Assessment of the effectiveness of a polypropylene onlay mesh in the prevention of laparoscopic trocar-site incisional hernia in high-risk patients. A randomized clinical trial.

purposeTrocar site incisional hernia (TSIH) is a common complication of laparoscopic surgery. In the scientific literature there are few descriptions of methods or tools for its prevention. The aim of this report was to assess the effectiveness and safety of a prophylactic measure designed to lower rates of TSIH.

methodsA multicenter randomized double-blinded clinical trial was performed in high-risk patients (diabetes mellitus and/or age ≥ 70 years and/or BMI ≥ 30 kg/m

resultsOne hundred and forty-three patients were randomized and finally 116 were analyzed (64 in the intervention arm and 52 in the control arm). Groups were homogeneous. Mean [SD] age, 65 [18] years; 86 (60.6%) were women. The cumulative TSIH incidence was lower in the intervention group although the differences did not reach statistical significance, assessed either radiologically (16 [25.4%] vs 17 [31.5%], p = 0.538) or clinically (9 [16.1%] vs 9 [20], p = 0.613). No differences in surgical site infection, hematoma or seroma were detected. Mean follow-up was 670 days (range 223-1294).

conclusionOur results show that, when properly assessed, the overall TSIH incidence is extremely high. Although polypropylene onlay mesh placement is safe, it does not appear to be effective in reducing the TSIH incidence rate. Radiological evaluation may be more accurate.

trial registrationClinicalTrials.org NCT03495557. Date of registration: April 12, 2018.