Randomized Prospective Trial on the Occurrence of Laparoscopic Trocar Site Hernias

Abstract

Laparoscopy has become the gold standard in an increasing number of procedures. We analyze the incidence of trocar site hernias (TSH) and determine whether closure of the external fascia prevents onset of TSH and possible complications. We performed a simple-blind randomized trial with two groups, one in which all the orifices were closed by suturing the external fascia of the abdominal wall (group A), and another in which the orifices were left open, closing only the skin (group B). Monitoring for TSH lasted 2 years from the intervention. The trial has been registered at www.clinicaltrials.gov with the clinicaltrials.gov identifier number: NCT01240434. A total of 195 patients were randomized. Thirty-three were removed from the study after conversion to open surgery, early open reoperation, or loss to follow-up. The remaining 162 patients comprised the study population, 80 in group A and 82 in group B. We found no differences between the groups regarding basic demographic data, kind of surgery, or topographic distribution of the trocars. Five TSH were diagnosed-four in group A and one in group B (P=.176)-and there was no relation between TSH and trocar size (11 or 12 mm) or location. We found 10 wound infections, 7 in group A and 3 in group B (P=.154). Our study suggests that the onset of TSH does not depend on trocar size or location. There is no evidence that suture of the fascial defect prevents the onset of TSH. In addition, we found a trend toward a higher incidence of wound infection among patients in whom the fascia had been sutured.