Robotic Surgery in the Seated Position for Benign and Malignant Lesions of the Head and Neck
Primary Purpose
Oropharyngeal Neoplasms, Head and Neck Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transoral Robotic Surgery (TORS) with the daVinci Robotic Surgical System device
Sponsored by
About this trial
This is an interventional other trial for Oropharyngeal Neoplasms focused on measuring Cancer, Oropharynx
Eligibility Criteria
Inclusion Criteria:
- Patient must present with indications for diagnostic or therapeutic surgery for benign or malignant diseases of the head and neck.
- Written informed consent.
Pre-Operative Exclusion Criteria:
- Unexplained fever and/or untreated, active infection.
- Patient pregnancy.
- Previous head and neck surgery precluding robotic procedures.
- The presence of medical conditions contraindicating general anesthesia or standard surgical approaches.
Intra-Operative Exclusion Criteria:
- It is recognized that sometimes patients cannot be excluded from study participation until prepped in the surgical suite such that their anatomy is exposed and available for medical analysis. The following situations represent instances whereby which patients would be excluded from this study based upon anatomical findings not evident in the pre-operative setting:
- Inability to adequately visualize anatomy or place robotic instrumentation to perform the diagnostic or therapeutic surgical approach in the seated position.
- In this circumstance, the procedure would be completed by standard robotic transoral surgery or an alternative approach may be chosen.
Sites / Locations
- Mayo Clinic in RochesterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Trans Oral Robotic Surgery (TORS)
Arm Description
Patient's are having TORS surgery in a seated position
Outcomes
Primary Outcome Measures
TORS surgery completion in the seated position
Recording how many participants' surgery was completed in the seated position
Secondary Outcome Measures
Length of participants' surgical time
Surgical start and stop times are recorded in the medical record
Estimated amount of blood loss during participants' surgery
Record blood loss during surgery as estimated by the lead surgeon
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02792322
Brief Title
Robotic Surgery in the Seated Position for Benign and Malignant Lesions of the Head and Neck
Official Title
A Pilot Study Assessing Robotic Surgery in the Seated or Supine Position for Benign and Malignant Lesions of the Head and Neck Using the da Vinci Robotic Surgical Systems and Modified Transoral Instrumentation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is designed to investigate if transoral surgery with the patient in the seated position utilizing the da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) will enable better visualization and expedited removal of benign and malignant tumors of the throat.
Detailed Description
The da Vinci Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) being evaluated in this pilot study consists of 3 basic components: a surgeon's console, articulated mechanical arms and sterilizable instruments. The console includes a computer, video monitor and instrument controls, and is located in the operating room adjacent to the operating room table. The console is connected via computer to the mechanical arms holding the endoscope (surgical TV camera) and sterile surgical tools (e.g., forceps, scissors, electrocautery, etc.). These arms are located immediately adjacent to the patient on the operating room table. The surgeon sits at the console and controls the position and movement of the arms and surgical tools. The design of these tools is based upon well-established, commonly used surgical instruments. The da Vinci Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) is a "manual image-guided surgery" system that is computer enhanced rather than "computer guided robotic surgery" in which the surgeon programs the computer to do the surgery and the robot does the surgery (also known as a "milling" device). Use of the da Vinci Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) in the aforementioned configuration in fact facilitates an exact translation of the surgeon's hand and finger movements at the console to precise and tremor-free movements of the arms and instruments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharyngeal Neoplasms, Head and Neck Cancer
Keywords
Cancer, Oropharynx
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Trans Oral Robotic Surgery (TORS)
Arm Type
Other
Arm Description
Patient's are having TORS surgery in a seated position
Intervention Type
Device
Intervention Name(s)
Transoral Robotic Surgery (TORS) with the daVinci Robotic Surgical System device
Other Intervention Name(s)
Da Vinci Robotic Surgical Systems
Intervention Description
Patient's will be having TORS surgery in a seated position
Primary Outcome Measure Information:
Title
TORS surgery completion in the seated position
Description
Recording how many participants' surgery was completed in the seated position
Time Frame
Measures assessed at time of intervention (during surgery)
Secondary Outcome Measure Information:
Title
Length of participants' surgical time
Description
Surgical start and stop times are recorded in the medical record
Time Frame
Measures assessed at time of intervention (during surgery)
Title
Estimated amount of blood loss during participants' surgery
Description
Record blood loss during surgery as estimated by the lead surgeon
Time Frame
Measures assessed at time of intervention (during surgery)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patient must present with indications for diagnostic or therapeutic surgery for benign or malignant diseases of the head and neck.
Written informed consent.
Pre-Operative Exclusion Criteria:
Unexplained fever and/or untreated, active infection.
Patient pregnancy.
Previous head and neck surgery precluding robotic procedures.
The presence of medical conditions contraindicating general anesthesia or standard surgical approaches.
Intra-Operative Exclusion Criteria:
It is recognized that sometimes patients cannot be excluded from study participation until prepped in the surgical suite such that their anatomy is exposed and available for medical analysis. The following situations represent instances whereby which patients would be excluded from this study based upon anatomical findings not evident in the pre-operative setting:
Inability to adequately visualize anatomy or place robotic instrumentation to perform the diagnostic or therapeutic surgical approach in the seated position.
In this circumstance, the procedure would be completed by standard robotic transoral surgery or an alternative approach may be chosen.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn Van Abel, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn Van Abel, MD
Phone
507-284-3542
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22386176
Citation
Moore EJ, Olsen SM, Laborde RR, Garcia JJ, Walsh FJ, Price DL, Janus JR, Kasperbauer JL, Olsen KD. Long-term functional and oncologic results of transoral robotic surgery for oropharyngeal squamous cell carcinoma. Mayo Clin Proc. 2012 Mar;87(3):219-25. doi: 10.1016/j.mayocp.2011.10.007.
Results Reference
background
PubMed Identifier
22752997
Citation
Weinstein GS, O'Malley BW Jr, Magnuson JS, Carroll WR, Olsen KD, Daio L, Moore EJ, Holsinger FC. Transoral robotic surgery: a multicenter study to assess feasibility, safety, and surgical margins. Laryngoscope. 2012 Aug;122(8):1701-7. doi: 10.1002/lary.23294. Epub 2012 Jul 2.
Results Reference
background
PubMed Identifier
4069324
Citation
Matjasko J, Petrozza P, Cohen M, Steinberg P. Anesthesia and surgery in the seated position: analysis of 554 cases. Neurosurgery. 1985 Nov;17(5):695-702. doi: 10.1227/00006123-198511000-00001.
Results Reference
background
PubMed Identifier
16464980
Citation
Engelhardt M, Folkers W, Brenke C, Scholz M, Harders A, Fidorra H, Schmieder K. Neurosurgical operations with the patient in sitting position: analysis of risk factors using transcranial Doppler sonography. Br J Anaesth. 2006 Apr;96(4):467-72. doi: 10.1093/bja/ael015. Epub 2006 Feb 7.
Results Reference
background
PubMed Identifier
22369328
Citation
Van Abel KM, Moore EJ. The rise of transoral robotic surgery in the head and neck: emerging applications. Expert Rev Anticancer Ther. 2012 Mar;12(3):373-80. doi: 10.1586/era.12.7.
Results Reference
background
PubMed Identifier
21344431
Citation
Moore EJ, Olsen KD, Martin EJ. Concurrent neck dissection and transoral robotic surgery. Laryngoscope. 2011 Mar;121(3):541-4. doi: 10.1002/lary.21435. Epub 2011 Jan 4.
Results Reference
background
PubMed Identifier
19342953
Citation
Weinstein GS, O'Malley BW Jr, Desai SC, Quon H. Transoral robotic surgery: does the ends justify the means? Curr Opin Otolaryngol Head Neck Surg. 2009 Apr;17(2):126-31. doi: 10.1097/MOO.0b013e32832924f5.
Results Reference
background
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Robotic Surgery in the Seated Position for Benign and Malignant Lesions of the Head and Neck
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