Department of Otolaryngology, Penn State Milton S Hershey Medical Center, 500 University Drive, Hershey, PA, United States.
Department of Otolaryngology, Penn State Milton S Hershey Medical Center, 500 University Drive, Hershey, PA, United States.
Int J Pediatr Otorhinolaryngol. 2022 Aug;159:111206. doi: 10.1016/j.ijporl.2022.111206. Epub 2022 Jun 13.
Transoral robotic surgery in adults confers excellent results and decreased morbidity. Application of these techniques has not yet been rigorously investigated in children. The goal of this study is to evaluate the feasibility of a flexible robotic surgical system in a pediatric population.
This was a non-randomized, non-blinded, prospective clinical trial. An Investigational Device Exemption was obtained from the FDA. Patients 8-12 years old scheduled for tonsillectomy and adenoidectomy between February and December 2019 at an academic tertiary care children's hospital were included. Exclusion criteria included pulmonary or vascular conditions posing risks for extended anesthesia, or a smaller mouth opening than the instrumentation (28 mm × 15 mm). Tonsillectomy was completed with standard monopolar cautery. After the surgery was complete, the robot was utilized for evaluation and assessment of exposure. A pediatric anesthesiologist screened patients for tolerance of additional anesthesia (up to 15 min). A flexible robotic surgical system, the MedRobotics Flex® Robotic System, was used to visualize and access the tonsillar fossa, posterior pharynx, base of tongue, epiglottis and false vocal folds. Visualization and access were graded on a five-point Likert scale.
A total of ten patients, eight males and two females, with obstructive sleep apnea (OSA) or sleep disordered breathing (SDB) were recruited in 2019. One patient did not complete the study due to equipment malfunction. The average patient demographics were: age 10.1 years (8.6-11.8 years), height 142.4 cm (127-164.9 cm), weight 47.5 kg (24.4-84.5 kg), and BMI 22.6 (13.9-31.0). Study time averaged 10.3 min (5-13 min). The tonsillar fossa, base of tongue, and posterior pharynx were visualized completely and easily accessed with the robotic instruments. The epiglottis and false vocal folds were visualized and accessed in 66% and 55% of patients, respectively. There were no adverse effects.
This study demonstrated that a flexible robotic surgical system is feasible for use in children 8-12 years of age when performing otolaryngology - head and neck surgery procedures of the oropharynx and larynx.
成人经口机器人手术可获得极佳的效果，并降低发病率。这些技术在儿童中的应用尚未经过严格的研究。本研究的目的是评估一种柔性机器人手术系统在儿科人群中的可行性。
这是一项非随机、非盲、前瞻性的临床试验。研究获得了 FDA 的调查设备豁免。2019 年 2 月至 12 月，在一家学术性三级儿童医院计划行扁桃体切除术和腺样体切除术的 8-12 岁患儿被纳入研究。排除标准包括存在延长麻醉风险的肺部或血管疾病，或张口度小于器械（28mm×15mm）。扁桃体切除术采用标准的单极电凝完成。手术完成后，使用机器人进行评估和评估暴露情况。一名儿科麻醉师对患儿是否能耐受额外麻醉（最长 15 分钟）进行筛查。使用 MedRobotics Flex®机器人系统对扁桃体窝、后咽、舌根、会厌和假声带进行可视化和操作。可视化和操作按五分制评分。
2019 年共纳入 10 例患者，8 例男性，2 例女性，均为阻塞性睡眠呼吸暂停（OSA）或睡眠呼吸障碍（SDB）。1 例患者因设备故障未完成研究。患者平均年龄为 10.1 岁（8.6-11.8 岁），身高 142.4cm（127-164.9cm），体重 47.5kg（24.4-84.5kg），体重指数 22.6（13.9-31.0）。研究时间平均为 10.3 分钟（5-13 分钟）。机器人器械可轻松完全地观察到扁桃体窝、舌根和后咽，并可轻松进入这些部位。66%和 55%的患者可观察到会厌和假声带，并可进入这些部位。没有不良影响。
本研究表明，当对 8-12 岁儿童进行口咽和喉咽耳鼻喉科手术时，一种柔性机器人手术系统是可行的。
