A randomised controlled trial comparing the LigaSure Retractable L Hook with the Harmonic ACE +7 Scalpel for use as a single instrument to complete a total laparoscopic hysterectomy for benign conditions in a normal sized uterus.

Hysterectomy for benign disease (eg. abnormal uterine bleeding, fibroid uterus, pelvic organ prolapse) is among the most commonly performed elective surgery for women. One in 3 women > 45 years has had a hysterectomy in Australia(1). Minimally invasive total laparoscopic hysterectomy (TLH) is overtaking open abdominal hysterectomy as a preferred approach in suitable cases due to reduced intra-operative blood loss, shorter hospital admissions, earlier return to normal activities and decreased cost(2,3) . Laparoscopic gynaecological electro-surgery has seen a steady evolution through monopolar, bipolar and now advanced vessel-sealing devices. Traditional monopolar energy devices are cost-effective and readily available. Its use is limited however, by excessive tissue charring and sticking, smoke production, lateral thermal spread and greater incidence of stray current injuries(4). Conventional bipolar devices are considered safer in terms of stray current injuries, but require a second instrument for tissue cutting, increasing instrument traffic and prolonging operative time(4). The introduction of advanced vessel sealing/dividing devices have addressed these limitations. Such devices offer the dual functionality of sequential tissue sealing and transection within a single device. There are several commonly used TGA-approved devices. The LigaSure Retractable L Hook vessel sealer/divider (Medtronic™) uses high-current, low voltage (80V) continuous bipolar radiofrequency energy to create a collagen/elastin vessel seal5. An advanced feedback system delivers and disrupts energy at the optimal tissue effect, as determined by impedance of tissue between the jaws of the device. Maximum temperatures reached are below 100 degrees Celsius reducing charring and sticking(5). In addition, the cold-cut blade allows the surgeon to transect the vessel at the site of sealing without needing to change to another instrument and at a time when the surgeon feels is safe to do so. Finally, the addition of a retractable L-Hook provides the addition of monopolar dissection which allows the surgeon to complete the colpotomy. The Harmonic ACE +7 uses rapid ultrasound energy rather than bipolar to achieve vessel sealing. Electrical energy is converted to ultrasound energy (55,000 cycles per second) and delivered to tissues on the active blade5. The denatured protein coagulum formed creates a seal for vessels up to 5-7 mm(6). The Harmonic Adaptive Tissue Technology claims to tailor energy delivery via enhanced feedback system, reducing unnecessary power delivery and possible thermal injury(7). The change in energy delivery is alerted to the surgeon via an audible activation tone. The Harmonic ACE +7 simultaneously seals and transects tissue, with three activation buttons on the handpiece: max, min and advanced. Max allows the fastest tissue cutting and can seal small vessels only, min allows vessel sealing up to 5mm and advanced allows vessel sealing up to 7mm6. In addition, the active blade can be used like an ultrasonic scalpel to perform transect tissue and perform a colpotomy. Whilst studies have been performed to assess both the Harmonic ACE +7 and the LigaSure Retractable L Hook as vessel sealing devices, these studies have mostly been animal studies(8,9). The aim of this study was to determine if advanced bipolar vessel sealing and division with the LigaSure Retractable L Hook provides improved surgical outcomes compared to ultrasonic vessel sealing and division with the Harmonic ACE +7 at total laparoscopic hysterectomy (TLH). TLH was chosen as the surgical steps are relatively similar, straightforward and reproducible, there is a variety of vessel diameters that need sealing (often up to 7mm) and there is a need to perform a colpotomy, which can now be performed by the same single energy device. References: 1) Australian Bureau of Statistics. National Health Survey: summary of results. 4364.0. 2004–2005. Canberra: Australian Bureau of Statistics, 2006. 2) De Cure N, Robson SJ. Changes in Hysterectomy Route and Adnexal Removal for Benign Disease in Australia 2001-2015: A national population-based study. Minim Invasive Surg. 2019;2018:5828071. DOI:10.1155/2018/5828071 3) Aarts JWM, Nieboer TE, Johnson N, Tavender E, Garry R, Mol BWJ, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database of Systematic Reviews 2015, Issue 8. Art. No.: CD003677. DOI: 10.1002/14651858.CD003677.pub5. 4) Lyons SD, Law KSK. Laparoscopic vessel sealing technologies. J Minim Invasive Gynecol. 2013 May-Jun;20(3):301-7 5) Jaiswal A, Huang KG. Energey devices in gynecological laparoscopy- archaic to modern era. Gynecol Minim Invasive Ther 2017; 6(4):147-151 6) Timm RW, Asher RM, Tellio KR, Welling AL, Clymer JW, Amaral JF. Sealing vessels up to 7mm in diameter solely with ultrasonic technology. Med Devices (Auckl) 2014; 7:263-271 7) Broughton D, Wlling AL, Monroe EH, Pirozzi K, Schulte JB, Clymer JW. Tissue effects in vessel sealing and transection from an ultrasonic device with more intelligent control of energy delivery. Med Devices (Auckl) 2013; 6:151-154 8) Lamberton GR, His RS, Jin DH, Lindler TU, Jellison FC, Baldwin DD. Prospective comparison of four laparoscopic vessel ligation devices. J Endourol. 2008 Oct;22(10):2307 9) Newcomb WL, Hope WW, Schmelzer TM, Heath JJ, Norton HJ, Lincourt AE< Heniford BT. Iannitti DA. Comparison of blood vessel sealing among new electrosurgical ultrasonic devices. Surg Endosc. 2009 Jan;23(10:90-6