Randomised Study Comparing Discharge 3 Days After Surgery to Home Within 24 Hours After Laparoscopic Hysterectomy.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Quality of life assessed by the Euroqol EQ-5D
研究概览
简要总结
Hysterectomy is one of the most performed surgery in gynecologic surgery. Actually, 70 000 hysterectomies are performed each year in France. Laparoscopic surgery is in progression. The percentage of hysterectomies performed laparoscopically is increasing. The advantage of laparoscopy include fewer infections, less operative pain, faster recovery time and shorter hospital stay. In France, the average of hospital stay after laparoscopic hysterectomy reduced to 3-4 days.
The study hypothesis is that a shorter postoperative stay does not decrease the quality of life of the patients.
This study will compare the evolution of quality of life (with a questionnaire concerning measuring health related quality of life the Euroqol EQ-5D) of patients discharged after 3 days hospital stay to patients discharged the first day after a laparoscopic hysterectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age between 35 and
- •affiliation to a social security system
- •signed informed consent form
- •disponibility of an responsible and valid accompanying person during 48 hours
- •home situation, less than one hour to go to an adapted structure of care
- •access to a phone
排除标准
- •comorbidity which will automatically increase the period of hospital stay
- •contraindication in laparoscopy
- •difficulty to understand the protocol
- •no social security cover
结局指标
主要结局
Quality of life assessed by the Euroqol EQ-5D
时间窗: up to 30th days after the laparoscopic hysterectomy.
Measure of quality of life with a questionnaire concerning health related quality of life (the Euroqol EQ-5D).The patients will complete the questionnaire at up to 30th days after the laparoscopic hysterectomy.
次要结局
- Perioperative morbidity(from intervention untill one month after intervention)
- Number of rehospitalization(one month after intervention)
- Quality of life with assessed by the short SF-36 score (the 36 items Short Form Health Survey). in pre-operative time and 30 days after the hysterectomy.(In pre-operative time and 30 days after the hysterectomy.)
- Patient satisfaction(Patient satisfaction assessed one month after intervention)
- Evaluation of pain by Visual Analog Scale for Pain and by analgesic drugs consumption(the day of intervention, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days and 30 days after intervention)
- Anxiety assessment by the State trait anxiety inventory forme Y-A(before intervention, the firt day, the second day, the third day after intervention, one week after intervention and one month after intervention.)
- Patient recovery and discharge after intervention assessed by Post-Anaesthetic Discharge Scoring System (PADSS score).(8 hours after laparoscopic surgery)
- Comparison between a hospital stay of 3-4 days after laparoscopic hysterectomy costs and hospital stay of 1day after laparoscopic hysterectomy costs from the day of intervention until one month after intervention.(each day from the date of intervention untill one month after intervention.)