Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck

Launched by OHIO STATE UNIVERSITY COMPREHENSIVE CANCER CENTER · Nov 14, 2011

Keywords

ClinConnect Summary

This clinical trial is studying a new type of surgery called transoral robotic surgery (TORS) to treat patients with various tumors in the head and neck. TORS is a less invasive procedure, meaning it may cause less damage to nearby tissues, potentially leading to fewer side effects and a quicker recovery compared to traditional surgery. The trial is currently looking for participants who have certain types of tumors in the oral cavity or throat and can safely undergo this procedure.

To be eligible, participants should have clear access to the affected areas for the robotic instruments, and they must be able to give their consent for the procedure. However, people with active infections, certain medical conditions, or who have had previous surgeries that complicate TORS may not be suitable for this trial. Those who join can expect to receive specialized care during the surgery and will help researchers learn more about the effectiveness of TORS in treating these tumors.

Gender

ALL

Eligibility criteria

• 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