Feasibility and Clinical Results of Implementation of ERAS® Guidelines for Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy: an International Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 288
- 试验地点
- 3
- 主要终点
- Compliance of ERAS® guidelines
研究概览
简要总结
Enhanced recovery after surgery (ERAS®) pathways have been shown to considerably reduce complications, length of stay and costs after most of surgical procedures by standardised application of best evidence-based perioperative care. Recently an international panel of expert have succeeded to elaborate dedicated recommendations for cytoreductive surgery (CRS) ± hyperthermic intraperitoneal chemotherapy (HIPEC) in a two-part series of guidelines based on expert consensus (Hübner et al., EJSO, 2020). The aim of this prospective validation study was therefore to study acceptance, feasibility and clinical results of these guidelines in clinical practice.
Hypothesis of the study: Introduction of ERAS® guidelines is feasible and safe. Increasing compliance with ERAS® guidelines (after implementation) will improve recovery and early clinical outcomes of patients undergoing CRS/HIPEC.
详细描述
The study includes two succesive phases interrupted by a stage to implement ERAS® guidelines.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults female and male patients (> 18 year-old)
- •Peritoneal cancer from colorectal, ovarian, gastric, appendix origin and primitive peritoneal cancer (peritoneal mesothelioma)
- •Multidisciplinary team meeting validation for CRS/HIPEC
- •Informed and signed surgical consent
排除标准
- •Patients without peritoneal cancer
- •Patients with peritoneal cancer and extended extraperitoneal metastases contraindicating for CRS with or without HIPEC
- •No informed consent signed
结局指标
主要结局
Compliance of ERAS® guidelines
时间窗: 3 months
Post-ERAS® implementation phase: compliance rate towards the relevant core items from ERAS guidelines
次要结局
- Acceptance and feasibility of ERAS® guidelines(3 months)
