Enhanced recovery after surgery in cytoreductive surgery with hyperthermic intraperitoneal chemotherapy in peritoneal carcinomatosis- compliance, safety & efficacy – a pilot study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. To assess the compliance of ERAS protocol in patients with peritoneal carcinomatosis undergoing CRS & HIPEC
研究概览
简要总结
CRS and HIPEC often involve complex surgical procedures in addition to intraperitoneal chemotherapy. These procedures are challenging & complex with multiple organ resection, prolonged operating time & complex hemodynamic changes during & after surgery. Enhanced recovery after surgery (ERAS) protocols are multimodal perioperative care pathways designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery. There are multiple studies which have proved the feasibility and improved outcomes of ERAS in gastrointestinal surgery & gynecological surgery but very few studies regarding ERAS in CRS & HIPEC. Present study will evaluate the safety & feasibility of ERAS protocol in CRS & HIPEC. It is expected that the ERAS protocol can hasten the recovery after CRS & HIPEC and decrease the in-hospital stay & morbidity
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with a peritoneal carcinomatosis undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy ii.
- •Peritoneal carcinomatosis Index (PCI) Score any iii.
- •Age >18 years and <65 years iv.
- •European Cooperative Oncology Group (ECOG) Performance status 0-1 vi.
- •No functional disturbance in bone marrow; WBC at least 3,000/mm3, Platelet count of atleast125,000/mm
- •No functional disturbance in liver; Bilirubin less than 2.5 mg/dL, PT-INR < 1.5 viii.
- •No function disturbance in kidney; Creatinine no greater than 1.5 times upper limit of normal.
排除标准
- 未提供
结局指标
主要结局
1. To assess the compliance of ERAS protocol in patients with peritoneal carcinomatosis undergoing CRS & HIPEC
时间窗: 30 Days
2. To identify the correlation of the compliance pattern with morbidity & mortality
时间窗: 30 Days
次要结局
- To assess the length of ICU stay, hospital stay & factors associated with morbidity.(30 days)