Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Lesions Using Da Vinci Robotic Surgical System

Wake Forest University (WFU)

Status

Completed

Conditions

Head and Neck Neoplasms

Treatments

Device: Da Vinci Robotic Transoral Robotic Surgical System

Study type

Interventional

Funder types

Other

Identifiers

NCT01059357

CCCWFU 60209 (Other Identifier)

IRB00009802

Details and patient eligibility

About

The purpose of this study is to conduct a pilot single-arm to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System.

Full description

Patients are going to be evaluated in their usual regular clinical follow ups starting with preoperative first visit, 3 weeks, 3 months and 6 months postoperatively with a Quality of Life survey (Head and Neck Cancer Inventory, HNCI-QOLQ).

Enrollment

58 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient must present with indications for diagnostic or therapeutic approaches for benign and malignant diseases of the oral cavity or laryngopharynx (including the neoplastic lesions of the tongue, tongue base, retromolar trigone, tonsils, palate, posterior and lateral pharynx, glottic, supraglottic and subglottic larynx)
Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation

Exclusion criteria

Unexplained fever and/or untreated, active infection
Patient pregnancy
Previous head and neck surgery precluding transoral/robotic procedures
The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches