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

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

Full Title of Study: “A Pilot Study Assessing Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Benign and Malignant Lesions Using the Da Vinci Robotic Surgical System”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2023

Detailed 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.

Interventions

  • Procedure: transoral robotic surgery
    • Undergo TORS using the Da Vinci Robotic Surgical System
  • Procedure: quality of life assessment
    • After surgery regular clinical assessments will be scheduled to see how the patient is doing. Patients will be asked to answer a quality of life assessment as part of the study. If patients are unable to come to the Ohio State University Medical Center for a physician appointment they will be contacted via phone or mailed a questionnaire to complete.

Arms, Groups and Cohorts

  • Experimental: Transoral robotic surgery (TORS)
    • Patients will undergo TORS for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System. After surgery regular clinical assessments will be scheduled to see how the patient is doing. Patients will be asked to answer a quality of life assessment as part of the study. If patients are unable to come to the Ohio State University Medical Center for a physician appointment they will be contacted via phone or mailed a questionnaire to complete.

Clinical Trial Outcome Measures

Primary Measures

  • Determine the feasibility of the TORS in patients with oral and laryngopharyngeal benign and malignant lesions.
    • Time Frame: up to eight years

Secondary Measures

  • Assess the impact of TORS on the intra-operative surgical outcomes such as operative time, blood loss and complications.
    • Time Frame: up to eight years
    • 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. 2. To identify the learning curve for TORS by measuring the efficiency and accuracy of the surgeons who perform the procedures.
  • Assess the quality of life of the patients with TORS.
    • Time Frame: up to eight years

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ohio State University Comprehensive Cancer Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Enver Ozer, Principal Investigator – Ohio State University Comprehensive Cancer Center
  • Overall Official(s)
    • Enver Ozer, MD, Principal Investigator, Ohio State University
  • Overall Contact(s)
    • Ohio State University Comprehensive Cancer Center, 1-800-293-5066, OSUCCCClinicaltrials@osumc.edu

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