Laparoscopic Abdominal Surgery Clinical Trial
Official title:
Evaluation of Safety and Efficacy of Using EndoClear-Endoscopic Lens Cleaning Device
Virtual Ports, Ltd., has developed a lens cleaning device, EndoClear, which is attached to the internal abdominal wall at the beginning of a surgical case and remains in position until completion of the surgery, enabling the surgeon to clean the camera lens without removing it from the abdominal cavity. The purpose of this study is to evaluate the efficacy and safety of using the EndoClear device as a laparoscopic lens cleaning device.
The ability to perform laparoscopic surgery safely and effectively depends on the
uninterrupted progression of the operation. Any interruptions to the normal workflow of the
procedure threatens to cause distraction which in the least can lengthen the operative time
leading to increased hospital operating costs and exposing the patient to unnecessary excess
anesthesia and associated risks. At worst, interruptions can cause errors in judgment and/or
technique resulting in injury to the patient.
Interruptions in the operating room can take many forms, from conversations to equipment
malfunction. The goal of this study is to focus on one particular type of interruption unique
to laparoscopic surgery - lens cleaning. It is quite common during the course of the
procedure for the laparoscopic scope lens to become obscured by bodily fluids or steam from
cautery devices. This necessitates having to remove the camera from the patient, cleaning it
outside of the body, applying de-fog solution, reinserting it into the body, and having to
reacquire the original camera position and image. This can be quite dangerous particularly in
the middle of operative step, such as when there is ongoing bleeding, or when there are sharp
or hot instruments within the body. Pilot data from own group demonstrates that the camera
may have to be cleaned up to 20 times during a case adding upwards of 10-15 minutes to an
operation.
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