Can FloSeal Reduce the Risk of Intra-abdominal Bleeding After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Performed for the Treatment of Peritoneal Carcinomatosis ?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Reoperation rate for intra-abdominal bleeding after CRS and HIPEC
研究概览
简要总结
Introduction
Modern treatment of peritoneal carcinomatosis (PC) combines an aggressive cytoreductive surgery (CRS) of all macroscopic disease and hyperthermic intraperitoneal chemotherapy (HIPEC) performed at the time of surgery. It is considered a high risk procedure and post-operative intra-abdominal bleeding is a major issue as it can delay recovery and promote intra-abdominal infections. In most severe cases (10 to 20% of patients), a second surgery to control the bleeding will be necessary. Major causes of bleeding are : radical resection, extensive peritonectomy, length of surgery, massive transfusion and use of HIPEC.
To reduce the risk of intra-abdominal hemorrhage, many strategies have been tried and one of these is the liberal use of FloSeal, but there is no data in this particular field of interest. Over the last 18 months, the investigators have started to use FloSeal in all their cases with large PC and they have observed a dramatic reduction in the rate of reoperation for bleeding and probably secondarily, in the use of blood products, but this has not been measured.
Hypothesis
FloSeal can reduce the risk of bleeding after CRS and HIPEC procedure.
Primary objective
To evaluate if the use of FloSeal can reduce the risk of reoperation after CRS and HIPEC procedure in the treatment of PC.
Secondary objectives
- To evaluate if the use of FloSeal can reduce operative blood loss.
- To evaluate if the use of FloSeal can reduce the need of blood products after CRS and HIPEC procedure.
- To evaluate if the use of FloSeal can have an impact on other common surgical complications (which can be indirectly bleeding related).
- To evaluate if the use of FloSeal can have an impact on length of hospital stay.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Male and female patients older than 18 year old
- •All cases of PC regardless of primary tumour (colorectal carcinoma, peritoneal mesothelioma, appendiceal carcinoma etc.)
排除标准
- •Prophylactic HIPEC
- •Peritoneal Carcinomatosis Index (PCI) < 5
结局指标
主要结局
Reoperation rate for intra-abdominal bleeding after CRS and HIPEC
时间窗: postoperative day O to hospital discharge (an expected average of 3 weeks after surgery)
次要结局
- Non-hemorrhagic complications(postoperative day 0 to hospital discharge (an expected average of 3 weeks after surgery))
- Length of hospital stay(postoperative day 0 to hospital discharge (an expected average of 3 weeks after surgery))
- Hemoglobin rate(at hospital discharge (an expected average of 3 weeks))
- Blood products use(during cytoreductive and HIPEC surgery and post-operative hospital stay (an expected average of 3 weeks))
- operative blood loss(Cytoreductive and HIPEC surgery)
研究者
Pierre Dubé
Surgical oncologist
Maisonneuve-Rosemont Hospital