Abstract
Purpose
Successful adoption of a new surgical procedure varies among practicing surgeons, and skill acquisition depends on the surgeon’s innate ability, the complexity of the technique, and training. We report intraoperative and near-term postoperative outcomes from the Acessa procedure conducted by minimally invasive gynecologic surgeons new to Acessa, and report the surgeons’ experiences during the training period.
Patients and methods
The study was designed as a postmarket, prospective, single-arm, multicenter analysis of operative and early postoperative outcomes after proctored surgical training with the Acessa device and procedure (laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation of symptomatic fibroids) in premenopausal, menstruating women as conducted in community and university hospitals in the USA and Canada. Surgeons completed evaluation forms once they felt they could safely and comfortably conduct the operations.
Results
Ten gynecologic surgeons without prior Acessa experience completed 40 Acessa procedures – all on an outpatient basis. Mean procedure time was 1.9±1.0 hours and was similar to that reported in the pivotal premarket study (2.1±1.0 hours). Two intraoperative complications occurred: a 1 cm uterine serosal laceration due to uterine manipulation and blood loss from both the probe insertion site and the lysis of uterine-omental adhesions. No postoperative complications or reinterventions for fibroid symptoms were reported. The surgeons completed the evaluation forms after two to five cases, and none found any factors affecting procedure efficiency to be inferior or needing improvement.
Conclusion
Minimally invasive gynecologic surgeons new to Acessa can perform the procedure and provide acceptable outcomes after two to five proctored cases.
Supplementary material
Table S1 List of institutional review boards that approved this study
Acknowledgments
The authors thank the following contributors: Halt Medical, Inc. (Brentwood, CA, USA) for surgical materials; Innovative Analytics (Kalamazoo, MI, USA) for data analysis support; and Wainwright Medical Communications (Los Gatos, CA, USA) for editorial support.
This paper was presented as a conference talk with interim findings at the 25th Annual Congress of the European Society of Gynaecological Endoscopy (ESGE); October 2–5, 2016; Square–Brussels–Belgium and the associated abstract was published in Gynecol Surg 2016;13 (Suppl 1):S126.
Disclosure
The authors report no conflicts of interest in this work.