Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery
Primary Purpose
Head and Neck Cancer, Oropharyngeal Cancer, Hypopharyngeal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
da Vinci® Robotic System
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring Lesions, Biopsy, Surgery
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.
Sites / Locations
- University of Alabama at Birmingham Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TORS Candidates
Arm Description
Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00473564
First Posted
May 14, 2007
Last Updated
February 5, 2016
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT00473564
Brief Title
Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery
Official Title
Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Oropharyngeal Cancer, Hypopharyngeal Cancer, Upper Aerodigestive Tract Neoplasms
Keywords
Lesions, Biopsy, Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TORS Candidates
Arm Type
Experimental
Arm Description
Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
Intervention Type
Procedure
Intervention Name(s)
da Vinci® Robotic System
Intervention Description
Head and Neck Surgery using the da Vinci® Robotic System
Primary Outcome Measure Information:
Title
Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions
Description
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
Secondary Outcome Measure Information:
Title
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.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Carroll, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20403855
Citation
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.
Results Reference
derived
PubMed Identifier
19643246
Citation
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.
Results Reference
derived
PubMed Identifier
19380364
Citation
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.
Results Reference
derived
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Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery
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