DARSH - A Multicenter Randomized Controlled Trial: Day-care vs Overnight Stay in Robotic Assisted Hysterectomy in Patients With Bening Disease and Endometrial Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Quality of life (QoL) day 3 after surgery compared to before surgery
研究概览
简要总结
Patients undergoing robotic assisted hysterectomy in three different hospitals in Stockholm will be randomized to day-care (going home the same day as the surgery) or admission (staying at least one night after surgery). The aim with this study is to investigate if patients in day-care recover as fast/faster as the other group that stays in the hospital. Both patients with benign disease and malign disease (endometrial cancer) will be included in the study.
Patients quality of life (QoL) will be measured before surgery and after surgery at day 3,7 and 30 with a questionnaire called Eq-5D-5L from Euroqol. The questionnaire is validated for postoperative QoL and widely used.
Complications due to surgery within the 30 first days after surgery will also be recorded in the two groups to make sure it is safe for the patients to go home the same day as their surgery.
详细描述
The study is a multicenter randomized non-inferiority trial. Three hospitals will participate in the study, Södersjukhuset and Danderyds sjukhus for benign indications, and Karolinska Sjukhuset Solna in case of endometrial cancer. The experimental group consisting of patients undergoing same-day discharge, while the control group consisting of patients admitted overnight. The study will use a 1:1 randomization ratio between the experimental and the control group with stratification for malignant and benign cases, given that Karolinska University Hospital Solna only handles endometrial cancer cases, while the other two sites handle benign cases exclusively.
To measure Quality of Life, the validated Euroqol instrument EQ-5D-5L will be used. The EQ-5D-5L instrument is well validated and used in several studies. The literature support that a 5 points difference at the visaul analog scale (VAS) scale is significant for better/worse health QoL.
To measure patient satisfaction with the length of hospital stay and care given they will at day 30 receive an additional questionnaire, the "Quality in patent perspective" (QPP), which is a validated questionnaire in Swedish.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient that are planned to undergo total robotic hysterectomy with or without adnexal surgery at the three sites.
- •Both benign conditions and endometrial cancer.
- •All BMI groups and all uterus sizes.
排除标准
- •Age not over 75 years old,
- •No company at home first night after surgery
- •ASA class 3 that is not only because of high BMI.
- •Simultaneous prolapse surgery/lymph node evacuation.
- •Severe endometriosis or patients with chronic pain conditions that have a special pain regimen after surgery.
研究组 & 干预措施
Day care
The patient returns to home the same day as the surgery is performed (before midnight)
干预措施: Day care (Other)
Overnight stay
The patient stay at the hospital overnight after their surgery.
干预措施: Overnight stay (Other)
结局指标
主要结局
Quality of life (QoL) day 3 after surgery compared to before surgery
时间窗: 3 days
Patients self reported quality of life (QoL) at a visual analog scale (VAS-scale) as reported in the 5-level EQ-5D Euroqol form (Eq-5d-5L) before surgery, compared with day 3 after surgery. The VAS-Scale goes from 0 to 100 where 0 i labeled "The worst health you can imagine" and 100 is labeled "The best health you can imagine". Compared between the two groups: day care and overnight stay.
次要结局
- Readmission(30 days)
- Quality of life (QoL) day 30 after surgery.(30 days)
- Complications after surgery(30 days)
- Reoperation(30 days)
- Sick leave after suregery(60 days.)
- Socioeconomic costs(30 days)
- Patient satisfaction with length of stay(30 days)
- Eq5D-5L index value of QoL.(30 days)
研究者
Malin Brunes
Principal Investigator
Karolinska Institutet