N/A
N=170
Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery
Head and Neck Cancer · Oropharyngeal Cancer · Hypopharyngeal Cancer · Upper Aerodigestive Tract Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00473564 ↗Enrolled (actual)
170
Serious AEs
12.4%
Results posted
Apr 2015
Primary outcome: Primary: Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions — 147; 23 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- da Vinci® Robotic System (Procedure)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions |
147; 23 | — |
| 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. |
17; 1; 14; 1; 1; 11 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00473564). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.