This clinical trial studies transoral robotic surgery (TORS) in treating patients with benign or malignant tumors of the head and neck. TORS is a less invasive type of surgery for head and neck cancer and may have fewer side effects and improve recovery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01473784.
Locations matching your search criteria
United States
Ohio
Columbus
Ohio State University Comprehensive Cancer CenterStatus: Active
Contact: Enver Ozer
Phone: 614-293-8074
PRIMARY OBJECTIVE:
I. To determine the feasibility of the TORS in patients with oral and laryngopharyngeal benign and malignant lesions and non-surgical patients.
SECONDARY OBJECTIVES:
I. To assess the impact of TORS on the intra-operative surgical outcomes such as operative time, blood loss and complications. If the planned procedure is a combined procedure, (robotic + non robotic) above mentioned measures are going to be presented separately for successful fully robotic surgeries and for unsuccessful mixed surgeries.
II. To identify the learning curve for TORS by measuring the efficiency and accuracy of the surgeons who perform the procedures.
III. To assess the quality of life (QOL) of the patients with TORS and without surgery.
IV. To assess the QOL of the patients with regard to swallowing for those with TORS and without surgery.
OUTLINE:
Patients undergo TORS using the Da Vinci Robotic Surgical System.
After completion of study treatment, patients are followed up at 3 weeks, 3 and 6 months, and then 1 year.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationOhio State University Comprehensive Cancer Center
Principal InvestigatorEnver Ozer