Vessel Sealing System Uvulopalatoplasty vs Uvulopalatal Flap: a Randomized, Control Study of Efficacy and Adverse Effects
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- intraoperative blood loss
研究概览
简要总结
The purpose of this study is to compare vessel sealing system uvulopalatoplasty (VSSU) to the traditional uvulopalatal flap (UPF) in the treatment of sleep-disordered breathing with special regard to intraoperative bleeding, operative time, postoperative pain, postoperative hemorrhage and other adverse effects.
详细描述
Uvulopalatopharyngoplasty is one of the common procedures performed by otolaryngologists to treat sleep-disordered breathing patients who have retropalatal obstruction. Intraoperative bleeding is a significant problem which requires hemostasis and causes prolonged operative time. Several different techniques are used to perform this operation, including cold knife, monopolar cautery, coblation, and radiofrequency. Efficacy in hemostasis and tissue trauma from different operative techniques may result in different operative time and different degrees of morbidity including intraoperative blood loss, postoperative pain, postoperative hemorrhage, and velopharyngeal insufficiency (VPI). The vessel sealing system has been widely used in head and neck surgery because of its effectiveness and safety. It was also found quite effective and safe in tonsillectomy procedures, providing excellent hemostasis and minimal tissue trauma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient planned for uvulopalatoplasty for indications of snoring or obstructive sleep apnea
- •Written informed consent form is given from patient
排除标准
- •Pregnancy
- •History of bleeding disorders
- •Patient unable to understand evaluation method
- •Patient unable to be contacted via telephone
结局指标
主要结局
intraoperative blood loss
时间窗: within the first 1 hour after surgery starting time
次要结局
- postoperative pain(within the first 14 days after surgery)
- postoperative bleeding(within the first 14 days after surgery)
- operative time(within the first 1 hour after surgery starting time)
- postoperative velopharyngeal insufficiency(within the first 3 months after surgery)
