Low vs Standard Pneumoperitoneum Pressure During Single Port Access Laparoscopic for Adnexal Pathology
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Postoperative pain measured on a VAS scale
研究概览
简要总结
During laparoscopy pneumoperitoneum creates the necessary space in which to perform the operation. Growing evidence in general surgery has shown that reduction of intra-abdominal pressure during laparoscopy is related to improved postoperative outcomes, decreased pain perception, length of hospital stay, and analgesic rescue dosage in patients undergoing minimally invasive procedures using low pneumoperitoneum pressure (LPP) compared with standard pneumoperitoneum pressure (SPP). Aim of the study is to demonstrate the safety and feasibility of LPP during performance of Single Port Access Laparoscopy for benign adnexal pathologies.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •patients 18- 45 years old
- •elective laparoscopic operation
- •informed consent
排除标准
- •BMI > 30 kg/cm2
- •pregnancy
- •converting to laparotomy
- •malignant disease
- •unable or unwilling to give written consent
结局指标
主要结局
Postoperative pain measured on a VAS scale
时间窗: 6 hours
Experienced pain over the last six hours measured on a VAS scale
次要结局
- Operation time(0 hours after the operation)
- Blood loss in ml(0 hours after the operation)
- Complications(Two months)
- Shoulder tip pain measured on a VAS scale(24 hours)
- Postoperative pain measured on a VAS scale(24 hours)
研究者
Stefano Angioni
Associate Professor
University of Cagliari