None of the procedures currently used to achieve access to the abdomen in laparoscopic surgery is totally efficacious or free of complications. Accordingly, several approaches and techniques have been investigated. Two such methods are the standard technique of insufflation by insertion of the Veress needle (VN) and direct trocar (DT) entry without prior pneumoperitoneum. Several studies have suggested that DT entry is a safe alternative to VN entry, but few were prospective and only 3 were randomized. Although DT is faster than any other method of entry, it is the least performed laparoscopic technique. Complications of laparoscopic surgery appear to be primarily entry-related and independent of surgical complexity. Several studies have suggested that the initial trocar insertion is the most dangerous step in minimally invasive surgery.
The aim of this randomized clinical trial was to compare DT to VN entry for the creation of pneumoperitoneum at laparoscopy with respect to the duration of the procedure, volume of gas used, ease of performance, and frequency of complications. A total of 1000 patients scheduled to undergo diagnostic laparoscopy were randomly assigned to receive DT (group A, n = 500) or VN (group B, n = 500) entry for pneumoperitoneum. The same surgeon performed the laparoscopic procedures.
There was no difference between the groups in demographic characteristics.
The mean duration of the procedure was significantly shorter in the DT group (2.2 ± 0.7 minute, 95% confidence interval [CI]: 2.14–2.26) compared to the VN group (8.2 ± 1.4 minute, 95% CI: 8.08–8.32; P < 0.0001). Similarly, the amount of gas consumed was significantly lower in the DT group (2.6 ± 0.9 L, 95% CI: 2.52–2.68) than in the VN group (8.4 ± 2.6 L, 95% CI: 8.17–8.63; P < 0.0001).
There were no major complications in either group. Compared to the patients in the DT group, those in the VN group had a significantly higher rate of minor intraoperative complications (VN: 14%, 95% CI: 10.96–17.4 vs. DT: 0.4%, 95% CI: 0.15–0.95; P < 0.0001).