Transoral Robotic Surgery (TORS) for Sleep Apnea

A Pilot Study Assessing Surgical Exposure During Transoral Robotic Surgery (TORS) for Sleep Apnea Using the da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA)

The purpose of this study is to assess if the da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) allows for "adequate exposure" for transoral resection of hypertrophic lingual tonsils in patients with obstructive sleep apnea.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Procedure: Transoral robotic surgery (TORS)

Detailed Description

Visit 1 - Outpatient Clinical Setting. The patient will be evaluated prior to treatment in the outpatient clinical setting in a way which is consistent for routine workup prior to any surgery of the tongue base for sleep apnea. This will include sleep nasendoscopy (see below), and if it is predicted pre-treatment that the transoral robotic approach may be appropriate then the patient will be given the option of participating in the study. This will include a review of the patient's pre-operative sleep study and a nasopharyngolaryngoscopic exam to assess for lingual tonsillar hypertrophy. A pre-operative MRI will be obtained to provide quantitative measurement of the patient's tongue base hypertrophy.

Visit 2 - Sleep Nasendoscopy. The patient will undergo sleep nasendoscopy as outlined below, in order to assess the involvement of the tongue base in the patient's sleep disordered breathing. This is a routine diagnostic procedure. Patients are pharmacologically induced into a light phase of sleep and the upper airway is visualized directly with a nasopharyngolaryngoscope. Anesthetic management will be performed in standard fashion, using propofol titrated to an endpoint of moderate sedation, as is typically done for procedural sedation in esophagogastroduodenoscopy. Administration will be logged to permit analysis of dosing requirements. Respiratory pattern will be monitored noninvasively and logged to permit correlation of obstruction to propofol administration.

Visit 3 - Intraoperative Setting. The patient will undergo an evaluation for "adequate exposure" for transoral robotic surgery and if "adequate exposure" is achieved then they will undergo transoral robotic surgery for lingual tonsillar hypertrophy to treat obstructive sleep apnea.

Visit 4 - Postoperative Setting. This will be in the inpatient and/or outpatient setting within three weeks of surgical procedure. The patient will undergo routine postoperative clinical evaluation.

Visit 5 - Postoperative Testing. The patient will undergo a follow-up sleep study to determine efficacy of the surgical procedure at three months post-operatively, the standard interval used to determine the outcome of the procedure.

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient is 18 or older at time of treatment.
• Patient must present with indications for surgical management of the tongue base to treat obstructive sleep apnea.
• Written informed consent and/or consent waiver by IRB.

Exclusion Criteria:

• Pre-operative exclusion criteria:
• Unexplained fever and/or untreated, active infection.
• Patient pregnancy.
• Previous head and neck surgery precluding transoral/robotic procedures.
• The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches.
• Intra-operative exclusion criteria (It is recognized that sometimes patients cannot be excluded from study participation until prepared in the surgical suite such that their anatomy is exposed and available for medical analysis. The following situations represent instances whereby patients would be excluded from this study based upon anatomical findings not evident in the pre-operative setting):
• Inability to adequately visualize anatomy to perform the diagnostic or therapeutic surgical approach transorally.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Transoral robotic surgery (TORS); da Vinci® Robotic Surgical System

Procedure: Transoral robotic surgery (TORS); 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 in the aforementioned configuration in fact facilitates an exact translation of the surgeons hand and finger movements at the console to precise and tremor-free movements of the arms and instruments.; Other Names: da Vinci® Robotic Surgical System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess if the da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) allows for "adequate exposure" for transoral resection of hypertrophic lingual tonsils in patients with obstructive sleep apnea.	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess ability to perform the transoral diagnostic removal of hypertrophic lingual tonsils using the robotic system for transoral resection of the tongue base in patients with obstructive sleep apnea.	1 year
To assess operative time to perform the transoral diagnostic removal of hypertrophic lingual tonsils using the robotic system for transoral resection of the tongue base in patients with obstructive sleep apnea.	1 year
To assess blood loss during the transoral diagnostic removal of hypertrophic lingual tonsils using the robotic system for transoral resection of the tongue base in patients with obstructive sleep apnea.	1 year
To assess complications of the transoral diagnostic removal of hypertrophic lingual tonsils using the robotic system for transoral resection of the tongue base in patients with obstructive sleep apnea.	1 year

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Erica Thaler, M.D., University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: February 19, 2010
• First Submitted That Met QC Criteria: August 20, 2010
• First Posted (Estimate): August 23, 2010

Study Record Updates

• Last Update Posted (Estimate): August 22, 2016
• Last Update Submitted That Met QC Criteria: August 18, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Obstructive sleep apnea
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 809623