An interventional study of Da Vinci Robotic Transoral Robotic Surgical System in Head and Neck Neoplasms, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-16.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
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.
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).
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 552 are open to participants now.
This study's enrollment of 58 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System
Device: Da Vinci Robotic Transoral Robotic Surgical System
(TORS) Da Vinci Robotic Transoral Robotic Surgical System
Also known as: (TORS) Da Vinci Robotic Transoral Robotic Surgical System
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
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
Number of Participants With Blood Loss and Complications
Time frame: 6 months
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
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
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
| Milestone | Transoral Robotic Surgery (TORS) |
|---|---|
| Started | 58 |
| Completed | 54 |
| Not completed | 4 |
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
| Participants | Transoral Robotic Surgery (TORS) |
|---|---|
| The Number and Percent of All Evaluable Patients Who Have Successfully Undergone TORS at Each Interim Analysis. | 54 |
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.
| minutes | Transoral Robotic Surgery (TORS) |
|---|---|
| Operative Time | 321 ± 136.63 |
| Participants | Transoral Robotic Surgery (TORS) |
|---|---|
| Number of Participants With Blood Loss and Complications | 7 |
This outcome is to identify the learning curve for TORS by measuring the efficiency of the surgeon who performs the procedures.
| minutes | Transoral Robotic Surgery (TORS) |
|---|---|
| Average Time to Set up and Perform Procedures | 109 ± 47.1 |
This outcome is to identify the learning curve for TORS by measuring the accuracy of the surgeon who performs the procedures.
| procedures | Transoral Robotic Surgery (TORS) |
|---|---|
| Number of Correctly Predicted Success of TORS Preoperatively | 53 |
Quality of life (QOL) of the patients undergoing TORS will be measures. The score range is 0-100 with higher scores denoting better outcome.
| score on a scale | Transoral Robotic Surgery (TORS) |
|---|---|
| QOL | 52 ± 13.2 |
Collected over up to 6 months. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Transoral Robotic Surgery (TORS) | 0/54 (0%) | 0/54 (0%) | 7/54 (13%) |
| Event | Transoral Robotic Surgery (TORS) |
|---|---|
| Postoperative bleedingBlood and lymphatic system disorders | 3/54 |
| Blood lossBlood and lymphatic system disorders | 2/54 |
| Chipped toothGeneral disorders | 1/54 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 1/54 |
| Age, Continuous(years) | Transoral Robotic Surgery (TORS) |
|---|---|
| Mean | 51.64 (27 to 80) |
| Sex: Female, Male(Participants) | Transoral Robotic Surgery (TORS) |
|---|---|
| Female | 15 |
| Male | 43 |
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Wake Forest University Health Sciences