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

NCT ID: NCT02792322

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-11
• Study Completion Date: 2024-05-07

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.

Conditions

Oropharyngeal Neoplasms; Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Trans Oral Robotic Surgery (TORS)

Patient's are having TORS surgery in a seated position

Group Type: OTHER

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

Intervention Type: DEVICE

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

Interventions

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

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

Intervention Type: DEVICE

Other Intervention Names

Da Vinci Robotic Surgical Systems

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.

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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Kathryn (Katie) M. Van Abel

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathryn Van Abel, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 3538408 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22752997 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 4069324 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16464980 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22369328 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21344431 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19342953 (View on PubMed)

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

NCI-2022-10968

Identifier Type: REGISTRY

Identifier Source: secondary_id

16-001297

Identifier Type: -

Identifier Source: org_study_id