Trial Outcomes & Findings for Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery (NCT NCT00473564)
NCT ID: NCT00473564
Last Updated: 2016-03-08
Results Overview
Number of participants with adequate exposure and access for use of the da Vinci® Robotic System in oropharyngeal and hypopharyngeal head and neck lesions
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
170 participants
Primary outcome timeframe
Intraoperatively average of 2 hours
Results posted on
2016-03-08
Participant Flow
Participant milestones
| Measure |
TORS Candidates
Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
|
|---|---|
|
Overall Study
STARTED
|
170
|
|
Overall Study
COMPLETED
|
147
|
|
Overall Study
NOT COMPLETED
|
23
|
Reasons for withdrawal
| Measure |
TORS Candidates
Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
|
|---|---|
|
Overall Study
robot surgery aborted in OR
|
23
|
Baseline Characteristics
Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery
Baseline characteristics by cohort
| Measure |
TORS Candidates
n=170 Participants
Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
113 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
57 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
127 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
154 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Intraoperatively average of 2 hoursNumber of participants with adequate exposure and access for use of the da Vinci® Robotic System in oropharyngeal and hypopharyngeal head and neck lesions
Outcome measures
| Measure |
TORS Candidates
n=170 Participants
Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
|
|---|---|
|
Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions
Number of participants with adequate exposure
|
147 participants
|
|
Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions
Number of participants without adequate exposure
|
23 participants
|
SECONDARY outcome
Timeframe: 3 - 24 months postoperativelyPopulation: Participants who successfully underwent transoral robotic-assisted surgery using the da Vinci® Robotic System
Assessment of patient safety evaluating the number of participants who experienced known complications from the use of the da Vinci® Robotic System during surgery, who experienced a need for conversion to open surgery during the procedure, or who required additional surgery for re-excision of the lesion due to positive margins
Outcome measures
| Measure |
TORS Candidates
n=147 Participants
Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
|
|---|---|
|
Assessment of Patients Safety by Evaluating the Number of Participants Who Experienced Known Complications From the Use of the da Vinci® Robotic System During Surgery, Experienced a Need for Conversion to Open Surgery or Required Additional Surgery.
Known complication: oral hemorrhage
|
17 participants
|
|
Assessment of Patients Safety by Evaluating the Number of Participants Who Experienced Known Complications From the Use of the da Vinci® Robotic System During Surgery, Experienced a Need for Conversion to Open Surgery or Required Additional Surgery.
Known complication: injury to perioral structures
|
1 participants
|
|
Assessment of Patients Safety by Evaluating the Number of Participants Who Experienced Known Complications From the Use of the da Vinci® Robotic System During Surgery, Experienced a Need for Conversion to Open Surgery or Required Additional Surgery.
Known complication: airway edema
|
14 participants
|
|
Assessment of Patients Safety by Evaluating the Number of Participants Who Experienced Known Complications From the Use of the da Vinci® Robotic System During Surgery, Experienced a Need for Conversion to Open Surgery or Required Additional Surgery.
Known complication: nerve injury
|
1 participants
|
|
Assessment of Patients Safety by Evaluating the Number of Participants Who Experienced Known Complications From the Use of the da Vinci® Robotic System During Surgery, Experienced a Need for Conversion to Open Surgery or Required Additional Surgery.
Need for conversion to open procedure during surge
|
1 participants
|
|
Assessment of Patients Safety by Evaluating the Number of Participants Who Experienced Known Complications From the Use of the da Vinci® Robotic System During Surgery, Experienced a Need for Conversion to Open Surgery or Required Additional Surgery.
Need for re-exicision due to positive margins
|
11 participants
|
Adverse Events
TORS Candidates
Serious events: 21 serious events
Other events: 121 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TORS Candidates
n=170 participants at risk
Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
aspiration pneumonia
|
1.2%
2/170 • 30 days
|
|
Metabolism and nutrition disorders
dehydration
|
2.9%
5/170 • 30 days
|
|
Gastrointestinal disorders
oral cavity hemorrhage
|
3.5%
6/170 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
diffuse pharyngeal swelling
|
0.59%
1/170 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
excessive mucus in throat
|
0.59%
1/170 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
ARDS with respiratory failure
|
0.59%
1/170 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia with respiratory distress
|
0.59%
1/170 • 30 days
|
|
Gastrointestinal disorders
dysphagia
|
1.2%
2/170 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
respiratory distress
|
1.2%
2/170 • 30 days
|
|
Cardiac disorders
myocardial infarction
|
0.59%
1/170 • 30 days
|
|
Musculoskeletal and connective tissue disorders
hip fracture
|
0.59%
1/170 • 30 days
|
|
General disorders
neck edema
|
0.59%
1/170 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
chylothorax
|
0.59%
1/170 • 30 days
|
|
Gastrointestinal disorders
vomiting
|
0.59%
1/170 • 30 days
|
|
Blood and lymphatic system disorders
leukocytosis
|
0.59%
1/170 • 30 days
|
Other adverse events
| Measure |
TORS Candidates
n=170 participants at risk
Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
|
|---|---|
|
Gastrointestinal disorders
dysphagia
|
31.2%
53/170 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
hoarseness
|
8.8%
15/170 • 30 days
|
|
Gastrointestinal disorders
oral pain
|
14.7%
25/170 • 30 days
|
|
Infections and infestations
oral yeast infection
|
5.9%
10/170 • 30 days
|
|
Musculoskeletal and connective tissue disorders
trismus
|
5.3%
9/170 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
laryngeal edema
|
5.3%
9/170 • 30 days
|
Additional Information
William Carroll, MD
University of Alabama at Birmingham
Phone: 205-934-9767
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place