Gan Philip, Bingham Judy
St John of God Hospital, Suite 7, 136 Botanic Road, Warrnambool, VIC, 3280, Australia.
Easington Pty Ltd, P.O. Box 1201, Camberwell, VIC, 3124, Australia.
Surg Endosc. 2016 Feb;30(2):789-796. doi: 10.1007/s00464-015-4272-0. Epub 2015 Jun 20.
All retractors for laparoscopic operations on the gallbladder or stomach apply an upward force to the under-surface of the liver or gallbladder, most requiring an additional skin incision. The LiVac laparoscopic liver retractor system (LiVac retractor) comprises a soft silicone ring attached to suction tubing and connected to a regulated source of suction. The suction tubing extends alongside existing ports. When placed between the liver and diaphragm, and suction applied, a vacuum is created within the ring, keeping these in apposition. Following successful proof-of-concept animal testing, a clinical study was conducted to evaluate the performance and safety of the retractor in patients.
The study was a dual-centre, single-surgeon, open-label study and recruited ten patients scheduled to undergo routine upper abdominal laparoscopic surgery including cholecystectomy, primary gastric banding surgery or fundoplication. The study was conducted at two sites and was approved by the institutions' ethics committees. The primary objective of the study was to evaluate the performance of the LiVac retractor in patients undergoing upper abdominal single- or multi-port laparoscopic surgery. Performance was measured by the attainment of milestones for the retractor and accessory bevel, where used, and safety outcomes through the recording of adverse events, physical parameters, pain scales, blood tests and a post-operative liver ultrasound.
The LiVac retractor achieved both primary and secondary performance and safety objectives in all patients. No serious adverse events and no device-related adverse events or device deficiencies were reported.
The LiVac retractor achieved effective liver retraction without clinically significant trauma and has potential application in multi- or single-port laparoscopic upper abdominal surgery. As a separate incision is not required, the use of the LiVac retractor in multi-port surgery therefore reduces the number of incisions.
所有用于胆囊或胃部腹腔镜手术的牵开器都会对肝脏或胆囊的下表面施加向上的力，大多数情况下需要额外的皮肤切口。LiVac腹腔镜肝脏牵开器系统（LiVac牵开器）包括一个连接到吸引管的软硅胶环，并与一个调节后的吸引源相连。吸引管沿着现有的端口延伸。当放置在肝脏和膈肌之间并施加吸引时，环内会产生真空，使它们保持贴合。在成功进行概念验证动物试验后，进行了一项临床研究以评估该牵开器在患者中的性能和安全性。
该研究是一项双中心、单术者、开放标签的研究，招募了10名计划接受常规上腹部腹腔镜手术的患者，包括胆囊切除术、原发性胃束带手术或胃底折叠术。该研究在两个地点进行，并获得了机构伦理委员会的批准。该研究的主要目的是评估LiVac牵开器在接受上腹部单端口或多端口腹腔镜手术患者中的性能。通过达到牵开器和辅助斜面（如使用）的里程碑来衡量性能，并通过记录不良事件、身体参数、疼痛量表、血液检查和术后肝脏超声来评估安全结果。
LiVac牵开器在所有患者中均实现了主要和次要性能及安全目标。未报告严重不良事件，也未报告与设备相关的不良事件或设备缺陷。
LiVac牵开器实现了有效的肝脏牵开，且无临床显著创伤，在多端口或单端口腹腔镜上腹部手术中具有潜在应用价值。由于不需要单独的切口，因此在多端口手术中使用LiVac牵开器可减少切口数量。
