Postoperative outcomes of oncology patients undergoing radical visceral resections - a multi-centric observational study (RaVisRO study).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- NA
- 入组人数
- 500
- 试验地点
- 18
- 主要终点
- Incidence of Clavien-Dindo postoperative complications and the Comprehensive Complication Index (CCI)
研究概览
简要总结
Onco-surgical procedures involving radical visceral resections often pose major challenges to the intensive care physicians and surgeons during the postoperative period. The higher morbidity and mortality rates noted are not only due to the complex nature of these surgical procedures, but also due to the postoperative stormy course that involves major fluid shifts, major blood loss, multiple blood transfusions, dyselectrolytemias, sepsis, anastomotic leaks, major adverse cardiac events, pulmonary complications and re-admission to intensive care unit (ICU). Various factors such as age, body mass index (BMI), American Society of Anesthesiologists (ASA) grade, pre-operative albumin levels, stage of cancer, surgical complexity, frailty status, duration of surgery, intraoperative blood loss, transfusion of blood products and cumulative fluid balance predict the occurrence of postoperative complications. The higher incidence of overall and severe complications (i.e., higher comprehensive complication index or CCI) noted in these patients especially during the immediate postoperative period can lead to increased length of stay (LOS) in the ICU and in the hospital, higher ICU re-admission rate, increased re-intubation rate and higher mortality rates. A thorough knowledge of these morbidity predictors, postoperative complications and outcomes can help in anticipation, prevention, early detection and timely management of these complexities. We, therefore intend to conduct a study to observe the outcomes following oncological surgeries that involve radical visceral resections.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •All patients aged 18 years and above who are undergoing elective onco-surgical procedures that involve radical visceral resections and are shifted postoperatively to the surgical ICU.
- •Cytoreductive surgery (CRS) plus Hyperthermic Intraperitoneal Chemotherapy (HIPEC) 2) Transthoracic esophagectomy (TTE) plus 3-field lymph node dissection 3) Hepatectomy 4) Parenchyma-sparing liver metastatectomy 5) Radical cholecystectomy 6) Extrahepatic biliary tree excision 7) Whipple’s procedure with or without vascular reconstruction 8) Retroperitoneal sarcoma excision 9) Pelvic exenteration surgery.
排除标准
- •Redo surgeries that involve radical visceral resections within 30 days of primary surgery will be excluded from the study.
结局指标
主要结局
Incidence of Clavien-Dindo postoperative complications and the Comprehensive Complication Index (CCI)
时间窗: at discharge and at 30 days
次要结局
- Morbidity predictors(90 days)
研究者
Dr Deepa Chandramohan
MVR Cancer Centre and Research Institute
