Penn-developed surgical procedure approved

The U.S. Food and Drug Administration has approved a technique for minimally invasive head and neck surgeries developed by two Penn Medicine surgeons in the Department of Otorhinolaryngology.

The transoral robotic surgery procedure, known as TORS, was approved for use with the robotic da Vinci Surgical System and requires no external incisions for surgical entry.

Robotic arms with five-millimeter instruments are inserted into the mouth, and are controlled by a surgeon using a remote console.

Penn surgeons Gregory Weinstein and Bert O’Malley founded the world’s first TORS program at Penn in 2004.

After publishing a study with researchers at Northwestern and Vanderbilt Universities, O’Malley and Weinstein were able to earn FDA approval for the TORS procedure in December.

Specifically, the FDA approved the TORS procedure for removal of all benign tumors and malignant tumors up to 4 centimeters in adults.

In response to the FDA concern that the procedure is not readily teachable, O’Malley said the study showed that only about 20 TORS surgeries are necessary “for other surgeons to be able to reach the comparative skill level of Dr. Weinstein and I.”

According to O’Malley, the technique reduces the traditional five-to-seven day recovery time for head and neck surgeries to only two or three days and saves patients a trip to the intensive care unit. It has also been shown to be a preferred option to chemotherapy, which is not invasive but “painful and destructive in its intensity” to eradicate tumors, O’Malley said.

“One of the key measures of quality of life is whether the patient needs a long-term stomach tube for feeding after these surgeries,” Weinstein said. “TORS shows at least an 8-percent improvement in swallowing function.”

The TORS procedure replaces traditional open surgery for head and neck tumors, which often involves making large incisions in the neck region, breaking the patient’s jawbone and removing large portions of tissue in a 12- to 14-hour operation, according to O’Malley and Weinstein.

“I believe a hundred percent that TORS will replace all classical head and neck cancer surgery in the areas in which it can be used,” said O’Malley. “It really is a paradigm shift in the way we treat head and neck cancers.”

While this is the first time that the TORS procedure has been approved on a national level, other procedures that use the da Vinci Surgical System have been approved, according to Aleea Farrakh, a spokesperson for the National Cancer Institute.

In 2007, Penn Medicine created an international training program to teach the TORS procedure to surgeons from ten countries on six continents.

According to the National Cancer Institute’s web site, head and neck cancers include those that arise in the nasal cavity, sinuses, lips, mouth, salivary glands, throat, voice box or other regions in the head. They account for approximately 3 to 5 percent of all cancers.

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