Clinical Trial Compares Laparoscopic vs. Natural Orifice Techniques
Surgeons at the University of California, San Diego Medical Center have performed the first clinical trial surgery in the Southwest to evaluate the safety and effectiveness of performing abdominal procedures through the body’s natural openings, virtually eliminating scarring.
The UCSD Medical Center procedure involved removing the gallbladder through the patient’s vagina without traditional incisions through the skin. Only one small incision through the navel was required to help guide the surgeon. This procedure received approval for a limited number of patients by UC San Diego’s Institutional Review Board (IRB) which oversees clinical research.
The procedure, called Natural Orifice Translumenal Endoscopic Surgery (NOTES), involves passing surgical instruments, and a tiny camera, through a natural orifice, such as the mouth or the vagina, to the desired organ. By avoiding major incisions through the skin, muscle, and nerves of the abdomen, patients may experience a quicker recovery with less pain and scarring while reducing the risk of post operative hernias.
Santiago Horgan, M.D., a leader in minimally invasive and robotic surgery, and Mark A. Talamini, M.D., professor and chair of the Department of Surgery at UC San Diego Medical Center performed California’s first NOTES surgery on a 42-year old San Diego resident. Her gallbladder was removed through the vagina during a 1.5 hour procedure. UC San Diego Medical Center is the third U.S.-based hospital to perform NOTES.
“We are testing a whole new approach to minimally invasive surgery,” said Horgan, director of minimally invasive surgery at UCSD Medical Center. “Yesterday’s procedure went exceptionally well and we look forward to studying and comparing all the study results to determine if this surgery is a desirable option for patients.”
A total of four patients will be recruited for the UC San Diego NOTES clinical trial. One more female patient will have her gallbladder removed through the vagina and two patients will have the organ extraction performed through the mouth. If the IRB determines that the procedures are safe, approval will be granted to enroll more patients.
“This emerging technique marks a pivotal time in the world of surgery and patient care,” said Talamini. “With this approach, we are hoping to take minimally invasive surgery one step further in terms of reducing pain, scarring, and recovery time.”
Horgan used FDA-approved RealHand High Dexterity (HD) instruments developed by Novare Surgical Systems, and a flexible endoscope, developed by Olympus to perform the NOTES procedure.
“By testing this novel approach, we may develop a technique that amplifies the trend of moving away from open cavity surgeries that involve major incisions and long hospitalizations to more minimally invasive outpatient procedures,” said Talamini. “We are refining techniques that will allow patients to return to their home, family and work more quickly.”
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