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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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01187160
Enrollment
154
Registered
2010-08-23
Start date
2009-10-31
Completion date
2014-11-30
Last updated
2016-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apnea

Brief summary

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.

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.

Interventions

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.

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026