Prophylactic mesh vs suture in the closure of the umbilical trocar site after laparoscopic cholecystectomy in high-risk patients for incisional hernia. A randomized clinical trial.

BACKGROUND: Prosthetic repair has become the standard method for hernia repair. Mesh placement for the prevention of trocar site incisional hernia (TSIH) is still a controversial issue. We tested the hypothesis that closure with an intraperitoneal prophylactic mesh of the umbilical trocar after a laparoscopic cholecystectomy can reduce the incidence of a TSIH in high-risk patients.

STUDY DESIGN: A randomized clinical trial was conducted among patients undergoing elective laparoscopic cholecystectomy who presented the following high-risk factors for incisional hernia, according to the literature: age 65 years and older, diabetes mellitus, chronic pulmonary disease, and obesity (ie, body mass index ≥30 kg/m(2)). Patients were assigned to have closure of the umbilical trocar site with either nonabsorbable sutures (group A) or intraperitoneal polypropylene omega-3 mesh (group B). Trocar site incisional hernia, pain, and surgical complications were evaluated at the early postoperative course and at 1, 6, and 12 months after surgery.

RESULTS: A total of 106 patients were randomized into the study and 92 patients were finally analyzed, including 47 in group A and 45 in group B. The TSIH rate was higher in group A (31.9%) than in group B (4.4%) (odds ratio = 10.1; 95% CI, 2.15-47.6; p < 0.001)). The wound infection rate was 4.3%; 8.5% in group A and 0% in group B (odds ratio = 2.04; 95% CI, 1.7-2.5; p = 0.045). Median postoperative pain evaluated by a visual analogue scale was 3 in group A and 2 in group B (p = 0.05). No differences were observed in complication rate, operative time, or hospital stay between the groups.

CONCLUSIONS: Prosthetic closure of the umbilical trocar site after laparoscopic surgery could become the standard method for preventing TSIH in high-risk patients.