Trial Information

A Pilot Study Assessing Transoral Robotic Surgery (TORS) For Oral And Laryngopharyngeal Benign And Malignant Lesions Using The da Vinci® Robotic Surgical System

In the past two decades the interest in minimally invasive techniques for transoral
treatment of head and neck benign and malignant lesions has been growing due to the
decreased morbidity of transoral approaches, and some surgeons have been moving away from
traditional open resections. Transoral resection of neoplasms of the upper aerodigestive,
by its minimally invasive nature, may afford a shorter hospitalization and recovery time for
patients when compared to those patients who undergo traditional "open" surgery. In surgery
of the oropharynx, hypopharynx, and larynx, transoral endoscopic surgery can provide similar
outcomes in terms of local control of disease when compared to open procedures, while
improving time to restoration of oral intake and shortening time to tracheostomy
decannulation. Therefore, in select patients, a transoral surgical approach may afford
clear advantages over traditional open approaches. Current techniques, however, are limited
by the inability to attain direct line of site exposure of the lesion. Use of
robot-assisted technology as a means to overcome surgical limitations, to provide surgeons
with improved dexterity and precision, and to couple advanced imaging techniques with
three-dimensional depth perception, may allow for the completion of transoral surgical
approaches in patients for whom conventional technology has been suboptimal.

The da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) is
FDA-approved for use in a variety of laparoscopic, thoracoscopic, cardiac, and urologic
surgical procedures. This protocol will assess the use of the da Vinci® Robotic Surgical
System (Intuitive Surgical, Inc., Sunnyvale, CA) in transoral surgeries in patients with
benign and malignant lesions of the oral cavity and laryngopharynx. Traditional endoscopic
removal of tumors of the oropharynx and laryngopharynx is usually preferred to traditional
open resection because of the decrease in morbidity and improved functional outcomes
experienced by patients. The limiting step in these procedures has been exposure of,
visualization of, and access to candidate tumors. The da Vinci surgical system offers the
possibility of significant improvements in exposure, visualization and access to these
candidate tumors with no added risk to patients. Overall this may significantly increase the
number of patients who are candidates for endoscopic surgery. Alternative procedures will
include traditional open surgical removal of tumors as well as traditional endoscopic
removal of tumors using the microscope and CO2 laser. Open surgical approaches are reserved
for patients who have large tumors unsuitable for endoscopic removal or in whom endoscopic
visualization of the tumor is inadequate or impossible. The da Vinci surgical system would
offer improved visualization of tumors that might otherwise be inaccessible to a traditional
endoscopic approach.

Candidate patients will present with a neoplasm of the oropharynx, hypopharynx or larynx.
Those patients assessed preoperatively to be candidates for transoral surgery (eg,
Mallampati class I or II, normal range of neck motion, no trismus) will undergo surgery via
a transoral approach to resect the tumor. This will require general anesthesia and may
require postoperative hospitalization. If the tumor can be accessed, resection will proceed
using the da Vinci robot. In whom the tumor cannot be accessed, resection will proceed via
the conventional open approach. Pre and postoperative care will not be affected by this
protocol, as it deals strictly with the manner in which the tumor is removed. Postoperative
care and visits are standardized as to the nature of the tumor (eg, malignant tumors usually
require follow-up visits every four to six weeks to monitor for tumor recurrence).
Complications, blood loss, operative time, length of hospitalization, time to resumption of
oral intake, time to decannulation, and overall local control rates will be assessed in the
postoperative period.