This prospective, interventional, non-randomized, single arm, clinical trial will investigate feasibility and safety of trans-oral robotic surgery using da Vinci SP Surgical System in Taiwan for the surgical treatment of OSA. All the investigators are well trained and have received proof of training after completing the training program for da Vinci SP system provided by Intuitive.
This study will be conducted in Chang Gung Memorial Hospital at Linkou. Informed consent will be provided to patient who has an indication of surgical treatment for OSA. Study participants will sign an informed consent before any study procedure begins. Eligibilities will be assessed during screening period (2 weeks) with blood test and other routine assessments. Eligible patient will undergo surgical intervention using da Vinci SP Surgical System. Post-operation follow-up will be performed at 1 week, 1 month, 3 months, and 6 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
The da Vinci SP Surgical System is intended to assist in the accurate control of the da Vinci SP endoscope and instruments during minimally invasive endoscopic abdominopelvic, thoracoscopic, transoral otolaryngology, and breast surgical procedures. The system is indicated for adult use. It is intended to be used by trained physicians in an operating room environment.
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan
Conversion rate
Success of tongue base resection without conversion to alternative surgery
Time frame: 3 months (+60 days) post-surgery
Apena Hypopnea Index
Type I PSG measurements demonstrating Apena Hypopnea Index (AHI) reduction. An AHI of \< 20 events/hour and a reduction in AHI of 50% or greater from baseline levels will be defined as success, when evaluated at 3 months (+60 days) post-surgery. Although it does not meet these criteria, it can be interpreted as an "improved" result when AHI is improved after surgery.
Time frame: 3 months (+60 days) post-surgery
Multi-level surgery
Multi-level surgery (procedure used)
Time frame: Intraoperative
Snoring Scale
Snoring VAS
Time frame: 3 months (+60 days) post-surgery
Operative time
Operative time (first skin incision to closure of wound)
Time frame: Intraoperative
Console time
Console time
Time frame: 3 months (+60 days) post-surgery
Transfusion and estimated blood loss
Transfusion and estimated blood loss
Time frame: 3 months (+60 days) post-surgery
Length of hospital stay
Length of hospital stay
Time frame: 3 months (+60 days) post-surgery
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Complication rate
Rate, intraoperative and/or postoperative, Clavien system
Time frame: 30 days
Readmission rate
Readmission rate
Time frame: 30 days
Reoperation rate
Reoperation rate
Time frame: 30 days
Perioperative mortality
Perioperative mortality
Time frame: 30 days
Volume of resected tissue
measured using the volume displacement method
Time frame: 3 months (+60 days) post-surgery
Pain score
Pain score (VAS)
Time frame: 3 months (+60 days) post-surgery
Sleepiness Scale
Epworth Sleepiness Scale (ESS) and Stanford Sleepiness Scale (SSS) at 3 months (+60 days) post-surgery compared to baseline
Time frame: 3 months (+60 days) post-surgery
Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index (PSQI) at 1, 3, 6 months post-surgery compared to baseline.
Time frame: at 1, 3, 6 months post-surgery
Adverse Events
Assessment of all reported adverse events (AE) within 3 months, (+60 days) post-surgery. Summarizing the incidence and frequency of all reported adverse events and categorizing them using CTCAE.
Time frame: within 3 months (+60 days) post-surgery