A Study Assessing Robotic Surgery in the Seated Position for Benign and Malignant Lesions of the Head and Neck Using the da Vinci Robotic Surgical System
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-001297
NCT ID: NCT02792322
Sponsor Protocol Number: 16-001297
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patient is ≥ 18 years old at time of treatment.
- 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.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 11/9/23. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
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Our objective was to determine the safety, feasibility, and the adequacy of surgical margins for transoral robotic surgery (TORS), by reviewing the early results from independent institutional review board-approved clinical trials in three separate institutions.
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The use of robotics in the field of head and neck surgery has provided surgeons with the ability to access anatomic locations that were previously only managed via open techniques. This has resulted in decreased overall morbidity, excellent functional results and the promise of equivalent oncologic outcomes. Transoral robotic surgery (TORS) provides access to the oropharynx, hypopharynx, larynx, oral cavity, parapharyngeal space and skull base vial the oral aperture. Studies reviewing the application of TORS to these subsites have been promising, and for many applications TORS has been accepted as a safe and efficacious option for surgical management. However, despite these promising results, TORS remains a surgical instrument that requires sound surgical skill, clinical judgment and oncologic principles, and should be chosen based on the needs of the individual patient and the comfort of the treating surgeon. In this article, we review the history of TORS, relevant anatomy and provide a review of the literature, highlighting the applications, advantages, functional outcomes and disadvantages of TORS for each anatomic subsite.
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To examine the long-term functional and oncologic results in patients who underwent transoral robotic surgery (TORS) as primary therapy or as part of combined therapy for oropharyngeal squamous cell carcinoma arising in the tonsil or base of tongue.
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1) Determine the incidence of pharyngocutaneous fistula associated with transoral robotic oropharyngectomy with concurrent neck dissection. 2) Discuss prevention and treatment of pharyngocutaneous fistulization as a consequence of transoral oropharyngeal surgery with concurrent neck dissection.
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Head and neck surgical science has developed dramatically during the past 20 years with a major focus on organ preservation surgery. Among these organ preserving surgeries are the selective neck dissections, supracricoid partial laryngectomies, transoral laser surgeries, and now a newcomer, transoral robotic surgery utilizing the da Vinci surgical system. Transoral robotic surgery is in its infancy, but, indeed, there have been some questions raised about the role of these innovative robotic surgical techniques.
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One major risk factor of the sitting position for neurosurgery is air embolism, especially in patients with persistent foramen ovale (PFO). The first aim of this prospective study was to evaluate a bedside method for detecting PFO using transcranial Doppler sonography (TCD) with contrast medium. A second aim was to address intraoperative monitoring, patient positioning and the occurrence and clinical relevance of air embolism.
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Because controversy exists regarding continued use of the seated position for neurosurgical procedures, this prospective (1981-1983) and retrospective (1972-1981) analysis of 554 seated patients was done to establish the incidence and severity of venous air embolism (VAE) related to type of surgical procedure and anesthetic technique; to examine the impact of specific monitoring practices on detection, morbidity, and mortality; and to establish the incidence of other complications related to the seated position (hypotension, quadriplegia, and arterial air embolism (AAE)). The overall morbidity and mortality related to the seated position was 1% (2 VAE, 1 AAE, 2 hypotension, 1 myocardial infarction) and 0.9% (1 VAE, 1 AAE, 2 hypotension, 1 quadriplegia), respectively. There has been no mortality since 1975. N2O did not seem to increase the incidence or severity of VAE. The seated position is safe in experienced hands if appropriate surgical and anesthetic skills are exercised in patient selection and management. Caution is advised in patients with atherosclerotic cardiovascular disease, severe hypertension, cervical stenosis, and right to left intracardiac shunts.
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