Comparison of surgical outcomes using Gyrus PKS™ vs LigaSure™ in total laparoscopic hysterectomy: A randomised controlled trial

Abstract

Background Advanced vessel sealing devices are widely used in laparoscopic surgery. However, there remains a lack of adequately powered trials comparing laparoscopic advanced vessel sealing devices in the clinical setting, especially in gynaecology. Aims This single‐blinded randomised controlled trial aims to compare the surgical outcomes of total laparoscopic hysterectomy (TLH) using either the Gyrus PKS™ LYONS dissecting forceps or the LigaSure™ Maryland jaw vessel sealer/divider. Materials and Methods Women who required TLHs for benign indications were randomised to having their surgeries performed using either Gyrus PKS™ or LigaSure™. Time to haemostasis (from initial skin incision to detachment of the uterus with secured haemostasis) was the primary outcome; a 20% difference in time was considered clinically significant. Secondary outcomes measured were intra‐operative blood loss, complications, conversions, post‐operative analgesia use, and length of stay. This study was registered with the Australia New Zealand Clinical Trials Registry ACTRN12615000639516. Results Sixty‐four women were included in the study – 33 and 31 in the Gyrus PKS™ and LigaSure™ arms, respectively. TLHs performed by LigaSure™ had statistically significantly shorter time to haemostasis compared to Gyrus PKS™ by 10.6 min (95% CI 1.3–2.0, P = 0.03). There were no differences in any of the other secondary outcomes measured. Conclusions This trial suggests there is no difference between using either device. TLHs performed using LigaSure™ have statistically significantly shorter time to haemostasis than those using Gyrus PKS™; however, the difference is not considered clinically significant as it was only 14.2%. No other differences in surgical outcomes were detected.

Advanced bipolar vessel sealing devices vs conventional bipolar energy in minimally invasive hysterectomy: a systematic review and meta-analysis

“…One study [ 24 ] was excluded from 15 studies [ 5 , 6 , 24 – 36 ], because it did not report data on relevant outcomes. Seven studies did not compare ABVS devices with conventional bipolar systems [ 6 , 25 , 27 , 28 , 31 , 33 , 34 ], two studies included hysterectomies for malignant indication [ 35 , 36 ]. One study reported supracervical laparoscopic hysterectomies [ 32 ].…”

“…Regarding total operative time, the observed reduction of 8 min did not allow us to suggest an economic advantage provided using ABVS devices in TLH. Considering the average cost of a standard operative room (5 Euro/minute) [ 5 , 34 ] and the higher cost of an ABVS device compared to conventional bipolar instruments, we could estimate the need for a 20–30 min reduction in total operative time to balance the increased expense [ 5 , 37 ]. One included study reported data stratified per learning curve [ 26 ].…”