Clinical Trial Surgery Studies the Safety and Effectiveness of Scarless Surgery
On Wednesday, March 12, 2008, surgeons at UC San Diego Medical Center performed what is believed to be the country’s first removal of a diseased appendix through the mouth. This clinical trial procedure received approval for a limited number of patients by UC San Diego’s Institutional Review Board (IRB) which oversees clinical research.
“The purpose of this clinical trial is to test more ‘patient-focused’ techniques for minimally invasive surgery,” said Mark A. Talamini, M.D., professor and chair of the Department of Surgery at UC San Diego Medical Center. “UC San Diego Medical Center is testing groundbreaking ways in which to perform surgery with fewer incisions, less pain, and more rapid recoveries.”
Santiago Horgan, M.D., professor and director of UC San Diego’s Center for the Future of Surgery, and Talamini, president elect of the Society of American Gastrointestinal and Endoscopic Surgeons, performed the surgery on Jeff Scholz, a 42-year old California resident. UC San Diego Medical Center is first U.S.-based hospital to perform this procedure. India is the only other country to report such an operation.
“UC San Diego’s Center for the Future of Surgery is advancing scarless techniques by investigating, developing, testing, and teaching procedures that will revolutionize the field of surgery,” said Horgan, president of the Minimally Invasive Robotics Association and a global leader in scarless procedures.
“Only one small incision to insert a small camera in the belly button was required to complete the surgery versus three incisions required for a laparoscopic procedure,” said Horgan. “The patient was discharged 20 hours after surgery and is now reporting minimal pain which is a goal for all of our patients.”
“I had to have my appendix removed and the opportunity to participate in something so innovative sounded enticing. A day after surgery, I have little pain, a ‘2’ on a scale of 1 to 10,” said Scholz, a resident of La Jolla. “My father had the conventional appendix removal. I didn’t want the standard issue scar on the abdomen.”
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, to the desired organ. By avoiding major incisions through the abdomen, patients may experience a quicker recovery with less pain while reducing the risk of post operative hernias.
Horgan and Talamini used FDA-cleared EndoSurgical Operating System (EOS) developed by USGI Medical, Inc. to perform the procedure. EOS was passed through the patient’s mouth and into the stomach where a small incision was made in the stomach wall to pass the instrument through to the appendix for removal.
In addition to Horgan and Talamini, the surgical team included: John Cullen, M.D., Garth Jacobsen, M.D., Karl Limmer, M.D., John McCarren, M.D., Bryan Sandler, M.D.and Thomas Savides, M.D.
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