The Pulmonary Effects of Low Pressure Versus Standard Pressure Laparoscopic Cholecystectomy in Patients With Cardiopulmonary Disorders: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Change of partial pressure of carbon dioxide（pCO2）
研究概览
简要总结
Standard Pressure Laparoscopic Cholecystectomy，as the standard for cholecystectomy, can lead to about 15% of pulmonary atelectasis. According to literature, low pressure laparoscopic cholecystectomy is thought to probably decrease cardio-pulmonary related complications and postoperative pain. However, the previous studies have presented controversial results. Our study aim to evaluate the potential pulmonary benefit of low pressure laparoscopic cholecystectomy in elderly or patients accompanied with cardio-pulmonary disorders.
详细描述
Standard Pressure Laparoscopic Cholecystectomy, SPLC；12-16mmHg，as the standard for cholecystectomy, can lead to about 15% of pulmonary atelectasis.
According to literature, Low Pressure Laparoscopic Cholecystectomy, LPLC；8-10mmHg is thought to probably decrease cardio-pulmonary related complications and postoperative pain. However, most of the existing study have combined population with all age scale, bringing bias to the result. Our study aim to evaluate the potential pulmonary benefit of low pressure laparoscopic cholecystectomy in elderly or patients accompanied with cardio-pulmonary disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
It will be single blinded. Operator, first assistant and data collector could not be blinded. Whereas patients, nurses, data analyzer, and those who have the access to the primary predictor will be blinded.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-85;
- •Patients receiving laparoscopic cholecystectomy due to benign gallbladder diseases;
- •Older patient or accompanied by cardiopulmonary diseases (age>60 years, hypertension, Diabetes Mellitus, coronary heart disease, arrhythmia, chronic bronchitis, emphysema, history of heart surgery, history of lung surgery, history of mediastinal surgery, asthma, et al);
- •Aged older than 60, with or without the above diseases;
- •American society of Aneshesiologists (ASA) II or higher;
- •Informed consent acquired.
排除标准
- •Having contraindication of laparoscopic operations;
- •History at epigastric surgery. -
结局指标
主要结局
Change of partial pressure of carbon dioxide（pCO2）
时间窗: Within postoperative 30 days.
Change of pCO2 in arterial blood gas test
次要结局
- visual analogue scale (VAS)(During postoperative 24 hours.)
- operation time(During surgery.)
- conversion rate to open surgery(During surgery.)
- complication rate(Within postoperative 30 days.)
研究者
Feng Tian
Attending
Peking Union Medical College Hospital