A Prospective Observational Study Comparing BiZact™, Coblation, and Bipolar Tonsillectomy Techniques
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Postoperative pain (Visual Analog Scale score)
研究概览
简要总结
This prospective, non-randomized observational study compared the surgical outcomes of BiZact™, Coblation, and Bipolar tonsillectomy techniques in pediatric and adult patients. Operative efficiency, postoperative pain, recovery parameters, postoperative bleeding, and device-related costs were evaluated.
详细描述
Tonsillectomy is a commonly performed surgical procedure in otorhinolaryngology, and various techniques have been developed to improve operative efficiency and postoperative recovery. This prospective, non-randomized observational study included 150 patients aged 5-40 years who underwent tonsillectomy between November 2024 and September 2025. Patients were allocated to Bipolar, Coblation, or BiZact tonsillectomy groups based on surgeon preference and device availability.
Primary outcome measures were operative time and postoperative pain assessed using the visual analogue scale on postoperative days 1, 3, and 7. Secondary outcomes included time to first solid food intake, length of hospital stay, postoperative bleeding, bleeding management, and device-related cost. The study aimed to compare clinical outcomes, recovery profiles, and procedural efficiency among the three tonsillectomy techniques.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 5 and 40 years
- •Undergoing tonsillectomy
- •Indication for surgery due to recurrent tonsillitis or obstructive sleep-related symptoms
排除标准
- •Known coagulation disorders
- •Presence of peritonsillar abscess
- •Presence of craniofacial syndromes
- •Incomplete follow-up data
研究组 & 干预措施
BiZact Tonsillectomy
Patients undergoing tonsillectomy using the BiZact™ device.
Coblation Tonsillectomy
Patients undergoing tonsillectomy using the coblation technique.
Bipolar Tonsillectomy
Patients undergoing tonsillectomy using bipolar electrocautery.
结局指标
主要结局
Postoperative pain (Visual Analog Scale score)
时间窗: Postoperative days 1, 3, and 7
Postoperative pain was assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores represent greater pain intensity.
Surgery time
时间窗: During surgery
次要结局
- Time to first solid food intake(Within the first postoperative week)
- Length of hospital stay(Postoperative Day 1)
- Postoperative bleeding(Up to 30 days postoperatively)
- Device cost per case(Perioperative period (day of surgery))
研究者
Oktay Bulut
Principal Investigator
Medicana Bursa Hospital