Head and Neck Neoplasms
Conditions
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).
Interventions
DEVICEDa Vinci Robotic Transoral Robotic Surgical System
(TORS) Da Vinci Robotic Transoral Robotic Surgical System
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transoral Robotic Surgery (TORS) Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System
Da Vinci Robotic Transoral Robotic Surgical System: (TORS) Da Vinci Robotic Transoral Robotic Surgical System | 58 |
| Total | 58 |
Baseline characteristics
| Characteristic | Transoral Robotic Surgery (TORS) |
|---|---|
| Age, Continuous | 51.64 years |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 54 |
| other Total, other adverse events | 7 / 54 |
| serious Total, serious adverse events | 0 / 54 |
Outcome results
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
Time frame: At time of surgery, lasting up to 3 hours. Assessed for up to 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transoral Robotic Surgery (TORS) | The Number and Percent of All Evaluable Patients Who Have Successfully Undergone TORS at Each Interim Analysis. | 54 Participants |
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.
Time frame: At time of surgery, up to 3 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transoral Robotic Surgery (TORS) | Average Time to Set up and Perform Procedures | 109 minutes | Standard Deviation 47.1 |
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.
Time frame: preoperative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Transoral Robotic Surgery (TORS) | Number of Correctly Predicted Success of TORS Preoperatively | 53 procedures |
Secondary
Number of Participants With Blood Loss and Complications
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transoral Robotic Surgery (TORS) | Number of Participants With Blood Loss and Complications | 7 Participants |
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.
Time frame: At time of surgery, up to 3 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transoral Robotic Surgery (TORS) | Operative Time | 321 minutes | Standard Deviation 136.63 |
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.
Time frame: 6 months
Population: Data not collected on all participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transoral Robotic Surgery (TORS) | QOL | 52 score on a scale | Standard Deviation 13.2 |