Skip to main content
OpenTrials
Completed

NCT Number: NCT01059357

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Da Vinci Robotic Transoral Robotic Surgical System

Device

(TORS) Da Vinci Robotic Transoral Robotic Surgical System

Other names: (TORS) Da Vinci Robotic Transoral Robotic Surgical System

Primary outcomes

  1. The Number and Percent of All Evaluable Patients Who Have Successfully Undergone TORS at Each Interim Analysis.

    Time frame: At time of surgery, lasting up to 3 hours. Assessed for up to 6 months

    In order to evaluate the feasibility of TORS, the investigators will report the number and percent of all evaluable patients who have successfully undergone TORS at each interim analysis

Secondary outcomes

  1. Operative Time

    Time frame: At time of surgery, up to 3 hours

    The total operative times include the induction of and emergence from anesthesia, the TORS procedure, plus any adjunct procedures (eg, neck dissections) performed during the same operation.

  2. Number of Participants With Blood Loss and Complications

    Time frame: 6 months

  3. Average Time to Set up and Perform Procedures

    Time frame: At time of surgery, up to 3 hours

    This outcome is to identify the learning curve for TORS by measuring the efficiency of the surgeon who performs the procedures.

  4. Number of Correctly Predicted Success of TORS Preoperatively

    Time frame: preoperative

    This outcome is to identify the learning curve for TORS by measuring the accuracy of the surgeon who performs the procedures.

  5. QOL

    Time frame: 6 months

    Quality of life (QOL) of the patients undergoing TORS will be measures. The score range is 0-100 with higher scores denoting better outcome.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Acronym: TORS

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jan 29, 2010
Registry last updated
Nov 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.