A Pilot Study Assessing Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Benign and Malignant Lesions Using the Da Vinci Robotic Surgical System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 58
- Locations
- 2
- Primary Endpoint
- The Number and Percent of All Evaluable Patients Who Have Successfully Undergone TORS at Each Interim Analysis.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Transoral Robotic Surgery (TORS)
Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System
Intervention: Da Vinci Robotic Transoral Robotic Surgical System (Device)
Outcomes
Primary Outcomes
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
- Operative Time(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(At time of surgery, up to 3 hours)
- Number of Correctly Predicted Success of TORS Preoperatively(preoperative)
- QOL(6 months)
