Comparison of Industry-Leading Energy Devices for Use in Gynecologic Laparoscopy: Articulating ENSEAL versus LigaSure Energy Devices

Abstract

Study objective: To compare 2 laparoscopic bipolar electrosurgical devices used in total laparoscopic hysterectomy (TLH). An articulating advanced bipolar device (ENSEAL G2; Ethicon Endo-Surgery, Cincinnati, OH) and an electrothermal bipolar vessel sealer (LigaSure; Medtronic, Minneapolis, MN) were analyzed for differences in surgeon perception of ease of instrument use and workload using the NASA Raw Task Load Index (RTLX) scale. A second objective was to examine differences in operative time, estimated blood loss (EBL), and perioperative complication rates between the 2 devices.

Design: Single-institution, single-blinded, randomized controlled trial (Canadian Task Force classification I).

Setting: Division of Minimally Invasive Gynecologic Surgery in a university hospital.

Patients: Eligibility required planned TLH, over age 18 years, and able to give informed consent; exclusions were stage III or IV endometriosis, known gynecologic malignancy, and early decision for conversion to laparotomy. One hundred seventy-eight patients screened, 142 enrolled, 2 withdrew, and 140 completed the study. Patients were followed 1 month postoperatively.

Interventions: Preoperative randomization to articulating advanced bipolar device or electrothermal bipolar vessel sealer to be used during TLH.

Measurements and main results: At the end of each hysterectomy the primary surgeon completed an ergonomic assessment tool, the RTLX. Results were analyzed to detect differences in workload between the 2 devices. For each case the time to ligation of the bilateral uterine arteries, EBL, and complications (including device failure, blood transfusion, or other injury) were recorded. Statistical analysis was performed using the t test for normally distributed data, χ² test for categorical data, and Mann-Whitney U-test for nonparametric data. There were no differences in age, body mass index, parity, prior surgery, uterine weight, race, indication, pathology, and comorbidities between the 2 groups. A statistically significant increase in RTLX scores (p < .0001), device failures (p = .0031), and time to ligation of bilateral uterine arteries (p = .0281) was noted in the articulating device group. No significant differences in EBL or complication rates were noted between the groups.

Conclusions: The articulating advanced bipolar device was shown to have a statistically significant increase in surgeon-perceived workload and rate of device failure when used in TLH; however, clinical and surgical outcomes were equivalent.

Keywords: Advanced vessel-sealing device; Energy devices; Ergonomics; Laparoscopic hysterectomy; Laparoscopy.