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

Not Applicable

Completed

• Conditions: Head and Neck Neoplasms
• Interventions: Device: Da Vinci Robotic Transoral Robotic Surgical System

• Registration Number: NCT01059357
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

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 Timeline

• Study First Submitted: 2010-01-21
• Study First Submitted QC: 2010-01-28
• Study First Posted: 2010-01-29
• Study Start: 2010-06
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Results First Submitted: 2018-09-21
• Status Verified: 2018-11
• Results First Submitted QC: 2018-11-13
• Last Update Submitted: 2018-11-13
• Results First Posted: 2018-11-16
• Last Update Posted: 2018-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transoral Robotic Surgery (TORS)	Da Vinci Robotic Transoral Robotic Surgical System	Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
Operative Time	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.
Number of Participants With Blood Loss and Complications	6 months
Average Time to Set up and Perform Procedures	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.
Number of Correctly Predicted Success of TORS Preoperatively	preoperative	This outcome is to identify the learning curve for TORS by measuring the accuracy of the surgeon who performs the procedures.
QOL	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.

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States