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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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

Detailed Summary: 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.
Sponsor: Enver Ozer

Current Primary Outcome: Determine the feasibility of the TORS in patients with oral and laryngopharyngeal benign and malignant lesions. [ Time Frame: up to eight years ]

Original Primary Outcome: Determine the feasibility of the TORS in patients with oral and laryngopharyngeal benign and malignant lesions. [ Time Frame: 2007-present ]

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Assess the impact of TORS on the intra-operative surgical outcomes such as operative time, blood loss and complications. [ Time Frame: 2007-present ]

    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: 2007-present ]


Information By: Ohio State University Comprehensive Cancer Center

Dates:
Date Received: November 7, 2011
Date Started: December 3, 2007
Date Completion: December 31, 2020
Last Updated: April 3, 2017
Last Verified: April 2017