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

A Pilot Study Assessing Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Benign and Malignant Lesions Using the 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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Neoplasms
• Intervention / Treatment: Device: Da Vinci Robotic Transoral Robotic Surgical System

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Transoral Robotic Surgery (TORS); Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System	Device: Da Vinci Robotic Transoral Robotic Surgical System; (TORS) Da Vinci Robotic Transoral Robotic Surgical System; Other Names: (TORS) Da Vinci Robotic Transoral Robotic Surgical System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number and Percent of All Evaluable Patients Who Have Successfully Undergone TORS at Each Interim Analysis.	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	At time of surgery, lasting up to 3 hours. Assessed for up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative Time	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.	At time of surgery, up to 3 hours
Number of Participants With Blood Loss and Complications		6 months
Average Time to Set up and Perform Procedures	This outcome is to identify the learning curve for TORS by measuring the efficiency of the surgeon who performs the procedures.	At time of surgery, up to 3 hours
Number of Correctly Predicted Success of TORS Preoperatively	This outcome is to identify the learning curve for TORS by measuring the accuracy of the surgeon who performs the procedures.	preoperative
QOL	Quality of life (QOL) of the patients undergoing TORS will be measures. The score range is 0-100 with higher scores denoting better outcome.	6 months

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Joshua D. Waltonen, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2010
• Primary Completion (ACTUAL): October 1, 2014
• Study Completion (ACTUAL): October 1, 2014

Study Registration Dates

• First Submitted: January 21, 2010
• First Submitted That Met QC Criteria: January 28, 2010
• First Posted (ESTIMATE): January 29, 2010

Study Record Updates

• Last Update Posted (ACTUAL): November 16, 2018
• Last Update Submitted That Met QC Criteria: November 13, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: IRB00009802; CCCWFU 60209 (OTHER: Wake Forest University Health Sciences)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes