Background: There have been reports in the literature regarding <1% incidence of port site

herniation without fascial closure of large bladeless trocar sites; a rate consistent with that of large bladed trocar sites with fascial closure. However, these reports are retrospective assessments of single procedures by individual surgeons. This prospective study was conducted by gynecological surgeons, in 12 different centers across the US in patients undergoing various Class I-IV laparoscopic surgeries. The incidence of symptomatic port site herniation with the placement of bladeless 10/11 mm and 10/12 mm trocars in the lower lateral quadrant without fascial closure was assessed.

Methods: In consenting patients, trocar size, type, location of use, degree of manipulation during surgery, fascial closure and type of surgery was documented. All eligible patients had at least one 10/11 or 10/12 bladeless non-midline trocar site without closure of fascia. All adverse events potentially related to the use of the trocars were captured. Port sites were evaluated by physical exam at 2 weeks and 6 months post op.

Results: 511 patients were enrolled into the trial. 500 patients completed the 14-day follow-up and 457 patients completed through the 6-month follow-up visit. A total of 1260 bladeless ports were placed (mean 2.5 trocars/patient); 848 were 10/11 or 10/12 mm bladeless trocars. 632 of the larger trocars were placed in the lower lateral quadrant; 216 in the umbilicus. Only 73/848 required fascial closure per assessment of the surgeon. No port site herniations were reported at 5 mm and 10/12 mm port sites and only one symptomatic herniation was reported at a 10/11 mm port site without fascial closure, at RLQ. No vascular or visceral injuries were caused by trocars, but other instruments caused vascular injuries in 3 subjects and visceral injuries in 7 subjects. 10 patients were converted to laparotomy for other reasons.