Overview
This pilot 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
Description
To conduct a pilot single-arm study to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System.
Eligibility
Inclusion Criteria:
- Patient must present with indications for diagnostic or therapeutic approaches for benign and/or 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
- Written informed consent and/or Consent waiver by institutional review board (IRB)
Exclusion Criteria:
- Unexplained fever and/or untreated, active infection
- Patient pregnancy
- Previous head and neck surgery that would preclude transoral/robotic procedures. This is at the investigator's discretion. This is not an exclusion criterion for the non-surgical arm.
- The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches
- Inability to grant informed consent
- INTRAOPERATIVE EXCLUSION CRITERIA:
- Inability to adequately visualize anatomy to perform the diagnostic or therapeutic surgical approach transorally