Head and Neck Cancer, Hypopharyngeal Cancer, Oropharyngeal Cancer, Upper Aerodigestive Tract Neoplasms
Conditions
Keywords
Lesions, Biopsy, Surgery
Brief summary
To evaluate the use of the daVinci Robotic System for better visibility and access of head and neck lesions and decreased amount of surgery time.
Detailed description
This trial is a single institution non-randomized study to evaluate the efficacy and safety of the da Vinci® Robotic Surgical System. This study will evaluate the use of the daVinci Robotic System for better visibility and access of head and neck lesions and decreased amount of surgery time. This is a robotic system used by surgeons to perform surgery in a less invasive manner.
Interventions
PROCEDUREda Vinci® Robotic System
Head and Neck Surgery using the da Vinci® Robotic System
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Head and neck lesions requiring surgical resection, biopsy, or invasive treatment; * Lesion amendable to robotic assisted surgery treatment; * Age \> 19 years; * Patient must sign informed consent.
Exclusion criteria
* Psychological condition that renders the patient unable to understand the informed consent; * Poor mouth opening, with maximal opening less than 1.5 cm.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions | Intraoperatively average of 2 hours | Number of participants with adequate exposure and access for use of the da Vinci® Robotic System in oropharyngeal and hypopharyngeal head and neck lesions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 3 - 24 months postoperatively | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TORS Candidates Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System | 170 |
| Total | 170 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | robot surgery aborted in OR | 23 |
Baseline characteristics
| Characteristic | TORS Candidates |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 57 Participants |
| Age, Categorical Between 18 and 65 years | 113 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 154 Participants |
| Sex: Female, Male Female | 43 Participants |
| Sex: Female, Male Male | 127 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 121 / 170 |
| serious Total, serious adverse events | 21 / 170 |
Outcome results
Primary
Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions
Number of participants with adequate exposure and access for use of the da Vinci® Robotic System in oropharyngeal and hypopharyngeal head and neck lesions
Time frame: Intraoperatively average of 2 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TORS Candidates | Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions | Number of participants with adequate exposure | 147 participants |
| TORS Candidates | 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
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.
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
Time frame: 3 - 24 months postoperatively
Population: Participants who successfully underwent transoral robotic-assisted surgery using the da Vinci® Robotic System
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TORS Candidates | 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 |
| TORS Candidates | 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 |
| TORS Candidates | 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 |
| TORS Candidates | 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 |
| TORS Candidates | 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 |
| TORS Candidates | 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 |