Fast-track in Minimally Invasive Gynaecology: a Randomized Trial Comparing Costs and Clinical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Hospital costs and ambulatory costs
研究概览
简要总结
Objective: Evaluate the effects of a fast-track (FT) protocol on costs and postoperative recovery.
Design: randomized trial
Setting: University Hospitals
Population: 170 women undergoing total laparoscopic hysterectomy for a benign indication
Methods: A FT protocol included the combination of minimally invasive surgery, analgesia optimization, early oral refeeding and rapid mobilization of patients was compared to a usual care protocol.
Main outcomes measure: Primary outcome was costs. Secondary outcomes were length of stay, postoperative morbidity and patient satisfaction.
详细描述
- Fast-Track protocol:
Preoperative
- Anesthetic consultation
- Proposal of optimization of patient's general health state + family meeting if necessary
- Hospitalization on day of surgery
- Solids stopped 6 hours prior to surgery, drinking encouraged up to 2 hours prior to surgery
During surgery
- Anti-infectious prophylaxis
- Anesthesia via IV propofol/remifentanil
- Anti-nausea prophylaxis
- Pain control based on limited systemic opioid use
Postoperative
- Balanced analgesia for pain control
- Antithrombotic prophylaxis
- Early oral refeeding
- Rapid mobilization
- Gum chewing
- Foley catheter removal at the end of surgery
- Peripheral IV catheter removal 6 hours postoperatively
- Usual care protocol :
Preoperative
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women undergoing total laparoscopic hysterectomy for a benign indication
排除标准
- •the requirement for an additional surgical procedure, such as prolapse repair or urinary incontinence, because a prolonged operative time could compromise early patient discharge and
- •the inability to speak French because the patients were required to complete their data collection logbook in French.
结局指标
主要结局
Hospital costs and ambulatory costs
时间窗: Up to 1 month postoperative
The economic evaluation covered hospital inpatient surgical care costs and ambulatory costs. Resource inputs were divided into two main categories: (1) hospital inpatient surgical costs and (2) ambulatory costs further divided into (2a) hospital-related costs (A\&E Department consultations and hospital readmission) and (2b) community costs (community health + social costs and caregiver's loss of production costs). Hospital costs were collected using a computerized hospital information system developed by the University Hospitals of Geneva. The patients recorded community costs in a logbook containing the community health and social invoices and caregivers' number of absent working days. Caregivers' loss of production was extrapolated via Switzerland's median wage per working day.
次要结局
- Postoperative morbidity rate during the first postoperative month(Up to 1 month postoperative)
- Hospital length of stay(Up to 1 month postoperative)
- Satisfaction assessed by a three-point likert scale(Up to 1 month postoperative)
研究者
Shahzia Lambat
Chief resident
University Hospital, Geneva