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临床试验/NCT05185791
NCT05185791Unknown不适用

Feasibility and Clinical Results of Implementation of ERAS® Guidelines for Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy: an International Prospective Cohort Study

Hospices Civils de Lyon3 个研究点 分布在 3 个国家目标入组 288 人开始时间: 2021年10月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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