Trial Outcomes & Findings for Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Lesions Using Da Vinci Robotic Surgical System (NCT NCT01059357)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

58 participants

Primary outcome timeframe

At time of surgery, lasting up to 3 hours. Assessed for up to 6 months

Results posted on

2018-11-16

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	58
Overall Study COMPLETED	54
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transoral Robotic Surgery (TORS) n=58 Participants 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
Age, Continuous	51.64 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Transoral Robotic Surgery (TORS) n=58 Participants 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
The Number and Percent of All Evaluable Patients Who Have Successfully Undergone TORS at Each Interim Analysis.	54 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Transoral Robotic Surgery (TORS) n=54 Participants 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
Operative Time	321 minutes Standard Deviation 136.63

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Transoral Robotic Surgery (TORS) n=54 Participants 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
Number of Participants With Blood Loss and Complications	7 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Transoral Robotic Surgery (TORS) n=54 Participants 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
Average Time to Set up and Perform Procedures	109 minutes Standard Deviation 47.1

SECONDARY outcome

Timeframe: preoperative

This outcome is to identify the learning curve for TORS by measuring the accuracy of the surgeon who performs the procedures.

Outcome measures

Outcome measures
Measure	Transoral Robotic Surgery (TORS) n=54 Participants 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
Number of Correctly Predicted Success of TORS Preoperatively	53 procedures

SECONDARY outcome

Timeframe: 6 months

Population: Data not collected on all participants

Quality of life (QOL) of the patients undergoing TORS will be measures. The score range is 0-100 with higher scores denoting better outcome.

Outcome measures

Outcome measures
Measure	Transoral Robotic Surgery (TORS) n=42 Participants 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
QOL	52 score on a scale Standard Deviation 13.2

Adverse Events

Transoral Robotic Surgery (TORS)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Transoral Robotic Surgery (TORS) n=54 participants at risk 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
Blood and lymphatic system disorders Blood loss	3.7% 2/54 • up to 6 months
General disorders Chipped tooth	1.9% 1/54 • up to 6 months
Respiratory, thoracic and mediastinal disorders Pneumonia	1.9% 1/54 • up to 6 months
Blood and lymphatic system disorders Postoperative bleeding	5.6% 3/54 • up to 6 months

Additional Information

Dr. Joshua Waltonen

Wake Forest University Health Sciences

Phone: 3367169068

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place