A Randomized, Controlled Study Evaluating The Effectiveness Of The Ultravision Visual Field Clearing System in Laparoscopic Hysterectomy and Myomectomy

Background: The smoke generated by electrosurgical devices in the process of dissection of tissues during laparoscopy can obscure the surgical visual field. Laparoscopic hysterectomy and laparoscopic myomectomy are procedures that produce a considerable amount of smoke, which impedes the operating surgeon. It is often necessary to suspend the surgery to allow the smoke to dissipate, or more commonly open a laparoscopic port to vent the smoke into the room, adding to the operating time. It is also common to remove the laparoscope to clean the lens because it can be soiled by the smoke as well. In order to enhance the dissipation of smoke and maintain an adequate pneumoperitoneum it is often necessary to increase the flow of carbon dioxide (CO2) from the insufflator. Surgical smoke handling during laparoscopic surgery results in an increase of the known risks to the patient of using excessive CO2; as well exposing the operating room staff to the smoke which may create a potential health concern. The electrostatic-precipitation of laparoscopic smoke is a new technique, marketed under the name Ultravision©, making it possible to precipitate the smoke as it is created, thereby actively eliminating it from the field of view. Safety and feasibility studies have been carried out allowing it to be placed on the market in Europe, Japan and the United States. A randomized study of its clinical effectiveness (ref: Ansell J. Surg, Endosc. (2014) 28: 2057-2065) showed that electrostatic-precipitation significantly improved visibility (reduction of visual impairment) and reduced surgery time in laparoscopic cholecystectomy. Ultravision is cleared for use in all laparoscopic surgery i.e. including laparoscopic hysterectomy and myomectomy, in the United States. However, the clinical benefits arising from its use in gynecology have not yet been quantitatively assessed and published in an independent medical journal.

Study Purpose: here are three main study objectives;

1. To evaluate the impact of use of Ultravision device during laparoscopic hysterectomy and myomectomy on the quality of visualization in the laparoscopic field
2. To evaluate the impact of use of Ultravision device during laparoscopic hysterectomy and myomectomy on procedural characteristics
3. To evaluate the impact of use of Ultravision device during laparoscopic hysterectomy and myomectomy on clinical outcomes.

Primary Hypothesis: The primary hypothesis being tested in this study is that using Ultravision during laparoscopic hysterectomy and myomectomy improves visualization similar to that reported when used in laparoscopic cholecystectomy without the need for CO2 exchange and that, by doing so, the amount of CO2 that the patient is exposed to is reduced compared to the current standard of care.

Secondary hypothesis: There are two aspects to CO2 exposure during laparoscopic surgery: the amount of gas used and the intra-abdominal pressure of the pneumoperitoneum. Ultravision has already been shown in laparoscopic cholecystectomy to minimize the amount of CO2 that a patient is exposed to during laparoscopic surgery because it does not rely on the process of dilution using ongoing CO2 supply from the insufflator. Decreasing the intra-abdominal pressure below the conventional 12-15 mmHg during laparoscopic surgery has been shown by others to lead to improved clinical outcomes in other laparoscopic procedures.