Impact of Intraperitoneal Pressure and Warmed, Humidified CO2 Gas on Clinical Outcomes After Laparoscopic Surgery for Uterine Prolapse in Patients Aged ˃75 Years: A Observational Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Quality of post-operative recovery assessed by the Quality of Recovery-40 questionnaire
研究概览
简要总结
The primary purpose is to evaluate the quality of post-operative recovery and post-operative pain in elderly patients (more than 75 years) who undergo laparoscopic surgery for uterine prolapse.
详细描述
Previous randomized clinical trial (NCT01887028) showed that the combined use of a low intraperitoneal pressure and a warmed, humidified CO2 gas resulted in better clinical outcomes (better quality of post-operative recovery and less post-operative pain) in patients aged 45-75 years, who underwent laparoscopic surgery for uterine prolapse.
Quality of post-operative recovery is very important in elderly patients. Investigators hypothesize that the combined use of a low intraperitoneal pressure and a warmed, humidified CO2 gas may also result in better clinical outcomes.
In this observational clinical trial, quality of post-operative recovery by QoR-40, post-operative pain by Visual Analog Scale, intra or postoperative complications and intraoperative core temperature are evaluated in elderly patients (more than 75 years old) who undergo laparoscopic surgery for uterine prolapse. Investigators use a low intraperitoneal pressure (6 mmHg) and a warmed, humidified CO2 gas during laparoscopy.
These outcomes will be compared with those of previous randomized clinical trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age more than 75 years old
- •Patients undergoing laparoscopic promontofixation with or without sub-total hysterectomy for uterine prolapse
- •ASA class I or II
排除标准
- •BMI more than 30
- •Height less than 150cm
结局指标
主要结局
Quality of post-operative recovery assessed by the Quality of Recovery-40 questionnaire
时间窗: at 48h post-operatively
Post-operative pain assessed by visual analogue scale in the word until discharge
时间窗: at 24h post-operatively
Post-operative pain assessed by visual analogue scale in the postanesthesia care unit
时间窗: at 24h post-operatively
次要结局
- post operative complications(at 24h post-operatively)
- Intraoperative core temperature(at 24h post-operatively)