Surgical Treatment for Patients With Obstructive Sleep Apnea by Using Da Vinci SP Surgical System

Официальное название

A Pilot Study of Single-port Robot-assisted Surgery Using da Vinci SP Surgical System for the Surgical Treatment for Patients With Obstructive Sleep Apnea

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Da Vinci SP Surgical System, Model SP1098
  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.

Первичные конечные точки

• Conversion rate [Срок оценки: 3 months (+60 days) post-surgery]
• Apena Hypopnea Index [Срок оценки: 3 months (+60 days) post-surgery]

Вторичные конечные точки (12)

• Multi-level surgery [Срок оценки: Intraoperative]
• Snoring Scale [Срок оценки: 3 months (+60 days) post-surgery]
• Operative time [Срок оценки: Intraoperative]
• Console time [Срок оценки: 3 months (+60 days) post-surgery]
• Transfusion and estimated blood loss [Срок оценки: 3 months (+60 days) post-surgery]
• Length of hospital stay [Срок оценки: 3 months (+60 days) post-surgery]
• Complication rate [Срок оценки: 30 days]
• Readmission rate [Срок оценки: 30 days]
• Reoperation rate [Срок оценки: 30 days]
• Perioperative mortality [Срок оценки: 30 days]
• Volume of resected tissue [Срок оценки: 3 months (+60 days) post-surgery]
• Pain score [Срок оценки: 3 months (+60 days) post-surgery]

Критерии участия

Критерии включения

• Age 18 years or more.
• OSA with AHI ≥ 15
• Has failed, refuses, or is unable to tolerate CPAP therapy
• Indication of resection of tongue base with/without other invasive surgical procedure for OSA (i.e. tongue base resection only or multi-level surgery with tongue base resection)
• ASA physical status classification 1-2 and adequate organ function
• Patients willing and able to comply with study protocol requirements and follow-up
• Informed consent

Критерии исключения

• BMI>35
• Mouth opening too narrow for TORS or trismus
• Betel nut chewing
• Suspicious cancer diagnosis
• Prior head-and-neck surgery (note: prior invasive therapy for OSA allowed)
• Other medical condition or anatomical factor not suitable for TORS, including subject with congenital malformations in the larynx, throat or tongue; 1. Subject with an American Society of Anesthesiologists (ASA) score of Grade 4 or above during preoperative evaluation
• Active infectious disease
• Can't follow trial-required procedures
• Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions

• Severe heart disease (NYHA functional class III-IV)
• Severe lung disease (GOLD Group C-D)
• Long-term use of anti-coagulant
• Patients with coagulopathy
• Emergency surgery
• Subject for whom any additional surgeries are planned for OSA within the study period, after the surgery in which the da Vinci SP System was used
• Subject is pregnant or suspected to be pregnant

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• Linkou Chang Gung Memorial Hospital — Taoyuan

Публикации

• Costantino A, Sampieri C, Meliante PG, De Virgilio A, Kim SH. Transoral robotic surgery in oropharyngeal squamous cell carcinoma: A comparative study between da Vinci Single-Port and da Vinci Xi systems. Oral Oncol. 2024 Jan;148:106629. doi: 10.1016/j.oraloncology.2023.106629. Epub 2023 Nov 14. PMID 37972462
• Baptista PM, Diaz Zufiaurre N, Garaycochea O, Alcalde Navarrete JM, Moffa A, Giorgi L, Casale M, O'Connor-Reina C, Plaza G. TORS as Part of Multilevel Surgery in OSA: The Importance of Careful Patient Selection and Outcomes. J Clin Med. 2022 Feb 14;11(4):990. doi: 10.3390/jcm11040990. PMID 35207264
• Lin HC, Friedman M. Transoral robotic OSA surgery. Auris Nasus Larynx. 2021 Jun;48(3):339-346. doi: 10.1016/j.anl.2020.08.025. Epub 2020 Sep 8. PMID 32917413
• Park YM, Kim DH, Kang MS, Lim JY, Choi EC, Koh YW, Kim SH. The First Human Trial of Transoral Robotic Surgery Using a Single-Port Robotic System in the Treatment of Laryngo-Pharyngeal Cancer. Ann Surg Oncol. 2019 Dec;26(13):4472-4480. doi: 10.1245/s10434-019-07802-0. Epub 2019 Sep 9. PMID 31502020
• Holsinger FC. A flexible, single-arm robotic surgical system for transoral resection of the tonsil and lateral pharyngeal wall: Next-generation robotic head and neck surgery. Laryngoscope. 2016 Apr;126(4):864-9. doi: 10.1002/lary.25724. Epub 2015 Oct 28. PMID 26509920
• Chen MM, Orosco RK, Lim GC, Holsinger FC. Improved transoral dissection of the tongue base with a next-generation robotic surgical system. Laryngoscope. 2018 Jan;128(1):78-83. doi: 10.1002/lary.26649. Epub 2017 Jul 6. PMID 28681924
• Maurice MJ, Kaouk JH. Single-Port Robot-Assisted Perineal Prostatectomy and Pelvic Lymphadenectomy: Step-by-Step Technique in a Cadaveric Model. J Endourol. 2018 May;32(S1):S93-S96. doi: 10.1089/end.2017.0707. PMID 29774808
• Chan JYK, Tsang RK, Holsinger FC, Tong MCF, Ng CWK, Chiu PWY, Ng SSM, Wong EWY. Prospective clinical trial to evaluate safety and feasibility of using a single port flexible robotic system for transoral head and neck surgery. Oral Oncol. 2019 Jul;94:101-105. doi: 10.1016/j.oraloncology.2019.05.018. Epub 2019 May 28. PMID 31178203

Идентификаторы

NCT: NCT06766760 · 113-01382A3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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