N/A
N=58
Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Lesions Using Da Vinci Robotic Surgical System
Head and Neck Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT01059357 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: The Number and Percent of All Evaluable Patients Who Have Successfully Undergone TORS at Each Interim Analysis. — 54 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Da Vinci Robotic Transoral Robotic Surgical System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number and Percent of All Evaluable Patients Who Have Successfully Undergone TORS at Each Interim Analysis. |
54 | — |
| SECONDARY Operative Time |
321 | — |
| SECONDARY Number of Participants With Blood Loss and Complications |
7 | — |
| SECONDARY Average Time to Set up and Perform Procedures |
109 | — |
| SECONDARY Number of Correctly Predicted Success of TORS Preoperatively |
53 | — |
| SECONDARY QOL |
52 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01059357). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.