Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| HNO 0601 | Other Identifier | UAB ComprehensiveCancerCenter ClinicalTrialsReviewCommittee |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TORS Candidates | Experimental | Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| da Vinci® Robotic System | Procedure | Head and Neck Surgery using the da Vinci® Robotic System |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Intraoperatively average of 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| William Carroll, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Medical Center | Birmingham | Alabama | 35233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20403855 | Derived | Dean NR, Rosenthal EL, Carroll WR, Kostrzewa JP, Jones VL, Desmond RA, Clemons L, Magnuson JS. Robotic-assisted surgery for primary or recurrent oropharyngeal carcinoma. Arch Otolaryngol Head Neck Surg. 2010 Apr;136(4):380-4. doi: 10.1001/archoto.2010.40. | |
| 19643246 | Derived | Iseli TA, Kulbersh BD, Iseli CE, Carroll WR, Rosenthal EL, Magnuson JS. Functional outcomes after transoral robotic surgery for head and neck cancer. Otolaryngol Head Neck Surg. 2009 Aug;141(2):166-71. doi: 10.1016/j.otohns.2009.05.014. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | TORS Candidates | Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TORS Candidates | Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | participants | Intraoperatively average of 2 hours |
|
|
30 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TORS Candidates | Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| aspiration pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Carroll, MD | University of Alabama at Birmingham | 205-934-9767 | wcarroll@uabmc.edu |
Not provided
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009959 | Oropharyngeal Neoplasms |
| D007012 | Hypopharyngeal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 3 - 24 months postoperatively |
| 19380364 | Derived | Boudreaux BA, Rosenthal EL, Magnuson JS, Newman JR, Desmond RA, Clemons L, Carroll WR. Robot-assisted surgery for upper aerodigestive tract neoplasms. Arch Otolaryngol Head Neck Surg. 2009 Apr;135(4):397-401. doi: 10.1001/archoto.2009.24. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | 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 | Participants who successfully underwent transoral robotic-assisted surgery using the da Vinci® Robotic System | Posted | Number | participants | 3 - 24 months postoperatively |
|
|
|
| 21 |
| 170 |
| 121 |
| 170 |
| dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| oral cavity hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
|
| diffuse pharyngeal swelling | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| excessive mucus in throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| ARDS with respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| pneumonia with respiratory distress | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
|
| respiratory distress | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| myocardial infarction | Cardiac disorders | Non-systematic Assessment |
|
| hip fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| neck edema | General disorders | Non-systematic Assessment |
|
| chylothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| leukocytosis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| hoarseness | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| oral pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| oral yeast infection | Infections and infestations | Non-systematic Assessment |
|
| trismus | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| laryngeal edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D010608 |
| Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| Title | Measurements |
|---|---|
|
| Known complication: nerve injury |
|
| Need for conversion to open procedure during surge |
|
| Need for re-exicision due to positive margins |
|