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

Head and Neck Neoplasms Clinical Trial

— TORS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01059357
• Other study ID #: IRB00009802
• Secondary ID: CCCWFU 60209
• Status: Completed
• Phase: N/A
• Start date: June 2010
• Est. completion date: October 2014

Study information

• Verified date: November 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

Device:
• Da Vinci Robotic Transoral Robotic Surgical System
(TORS) Da Vinci Robotic Transoral Robotic Surgical System

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of Participants With Blood Loss and Complications		6 months
Secondary	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
Secondary	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
Secondary	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