Robotic Surgery in the Seated Position for Benign and Malignant Lesions of the Head and Neck

NCT02792322 | Completed DMC

• 2 other identifiers: 16-001297NCI-2022-10968
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Oropharyngeal Neoplasms; Head and Neck Cancer

Keywords

Cancer; Oropharynx

Outcome Measures

Primary Outcomes (1)

• TORS surgery completion in the seated position

  Recording how many participants' surgery was completed in the seated position

  Measures assessed at time of intervention (during surgery)

Secondary Outcomes (2)

• Length of participants' surgical time

  Measures assessed at time of intervention (during surgery)

• Estimated amount of blood loss during participants' surgery

  Measures assessed at time of intervention (during surgery)

Study Arms (1)

Trans Oral Robotic Surgery (TORS)

OTHER

Patient's are having TORS surgery in a seated position

Device: Transoral Robotic Surgery (TORS) with the daVinci Robotic Surgical System device

Interventions

Transoral Robotic Surgery (TORS) with the daVinci Robotic Surgical System device DEVICE

Patient's will be having TORS surgery in a seated position

Also known as: Da Vinci Robotic Surgical Systems

Trans Oral Robotic Surgery (TORS)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must present with indications for diagnostic or therapeutic surgery for benign or malignant diseases of the head and neck.
• Written informed consent.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (7)

• Holzgreve W, Miny P, Holzgreve A, Rehder H. [Ultrasound findings as a sign of fetal triploidy]. Ultraschall Med. 1986 Aug;7(4):169-71. doi: 10.1055/s-2007-1011939. German.

  PMID: 3538408 BACKGROUND

• 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.

  PMID: 22752997 BACKGROUND

• 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.

  PMID: 4069324 BACKGROUND

• 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.

  PMID: 16464980 BACKGROUND

• 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.

  PMID: 22369328 BACKGROUND

• 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.

  PMID: 21344431 BACKGROUND

• 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.

  PMID: 19342953 BACKGROUND

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Oropharyngeal Neoplasms; Head and Neck Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Neoplasms by Site; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Kathryn Van Abel, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: June 7, 2016
• Study Start: July 11, 2016
• Primary Completion: May 7, 2024
• Study Completion: May 7, 2024
• Last Updated: June 4, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)