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

Wake Forest University Health Sciences58 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head and Neck Neoplasms

Interventions

Da Vinci Robotic Transoral Robotic Surgical SystemDEVICE

(TORS) Da Vinci Robotic Transoral Robotic Surgical System

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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.

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

Number of Participants With Blood Loss and Complications

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 6 months

Data from ClinicalTrials.gov

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