Clinical trial · Interventional
Robotic Surgery in the Seated Position for Benign and Malignant Lesions of the Head and Neck
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
NCT02792322CI-TRIAL-00090523completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Oropharyngeal Neoplasms | Oropharyngeal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transoral Robotic Surgery (TORS) with the daVinci Robotic Surgical System device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Trans Oral Robotic Surgery (TORS)
- description
- Patient's are having TORS surgery in a seated position
- interventionNames
- Device: Transoral Robotic Surgery (TORS) with the daVinci Robotic Surgical System device
Primary outcomes (1)
- measure
- TORS surgery completion in the seated position
- timeFrame
- Measures assessed at time of intervention (during surgery)
- description
- Recording how many participants' surgery was completed in the seated position
Secondary outcomes (2)
- measure
- Length of participants' surgical time
- timeFrame
- Measures assessed at time of intervention (during surgery)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (7)
- BACKGROUNDMoore 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. PMID 22386176
- BACKGROUNDWeinstein 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. PMID 22752997
- BACKGROUNDMatjasko 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. PMID 4069324
- BACKGROUNDEngelhardt 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. PMID 16464980
- BACKGROUNDVan 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. PMID 22369328
- BACKGROUNDMoore 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. PMID 21344431
- BACKGROUNDWeinstein 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.