Prospective Randomized Controlled Study Comparing Peak Expiratory Flow (PEF) Changes After Robot-Assisted and Open Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in PEF (L/min)
研究概览
简要总结
This prospective, randomized controlled trial aims to compare perioperative respiratory changes in patients undergoing robot-assisted laparoscopic radical prostatectomy (RALRP) and open radical prostatectomy (ORP). The primary outcome is the change in peak expiratory flow (PEF) from the preoperative period to the early postoperative (2nd hour) period. Secondary outcomes include PEF recovery at 24 hours, and correlations between PEF change and intraoperative factors such as Trendelenburg angle, pneumoperitoneum duration, and ventilatory parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, 18-80 years old
- •ASA physical status I-III
- •Scheduled for open or robot-assisted radical prostatectomy
- •Able to provide informed consent and follow Turkish instructions
排除标准
- •Moderate/severe COPD (GOLD II-IV)
- •Active upper respiratory tract infection
- •Severe OSA requiring CPAP
- •Inability to perform standardized PEF maneuver
- •Emergency surgery
- •Cognitive impairment preventing participation
结局指标
主要结局
Change in PEF (L/min)
时间窗: From preoperative baseline to postoperative 2nd hour
Difference between preoperative and early postoperative PEF values.
次要结局
- Incidence of respiratory complications(Within the first 24 hours after surgery)
- Change in PEF from preoperative to postoperative 24th hour(From preoperative measurement (baseline) to postoperative 24th hour)
- Intraoperative parameters correlated with PEF reduction(From induction of anesthesia to end of surgery)
研究者
Betül Güven
Principal Investigator
Ankara City Hospital Bilkent