Impact of Preoperative Single Corticosteroid Flash on Morbidity After Colorectal Resection: Monocentric Prospective Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Frequency of postoperative complications, occuring up to 30 days post-operatively
研究概览
简要总结
Complications due to infection after colorectal surgery are frequent, affecting up to 25% of patients. Infection increases mortality, lengthens hospital stays, increases costs and decreases long term survival for cancer patients. Perioperative inflammation leads to hypercatabolism, denutrition and immunosuppression, all of which are associated to postoperative infection. Data from various sources suggests that modulating perioperative inflammatory response through the injection of corticosteroids would benefit the patient by reducing the number of postoperative complications after major surgery. Pre- or perioperative intravenous administration of a single corticosteroid flash is a means of modulating systemic inflammation that has been suggested for numerous types of surgeries, including pancreatic surgery. The objective of this study is to assess whether a preoperative single corticosteroid flash (methylprednisolone: 20 mg/kg IV at anesthetic induction) reduces the risk of serious complications after elective colorectal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adult patient
- •Patient undergoing elective colorectal surgery (diverticulitis, malignant or benign tumor, inflammatory intestinal disease, re-establishing continuity, endometriosis, or other)
- •Bowel continuity is restored immediately after surgery, with or without a protective stoma.
- •Patient with proper understanding who has been informed about the study, and who has consented to being part of the study
排除标准
- •Adult under guardianship
- •Patient who is not covered under the national health system
- •Women who are pregnant or breastfeeding
- •Colorectal resection with concomitant hyperthermic intraperitoneal chemotherapy
- •Patient under long term corticosteroid therapy
- •Preoperative natremia > 147 mmol/L
- •Hypokalemia (< 3,3 mmol/L)
- •Patient with a contraindication to Methylprednisolone Mylan® :
- •Active infection
- •Active viral disease (namely hepatitis, herpes, varicella, shingles),
- •A psychotic condition that is not currently treated with medication,
- •Vaccination with a live vaccine or live attenuated within the last 3 months,
- •Hypersensitivity to methylprednisolone or to any of the excipients found in Methylprednisolone Mylan®
结局指标
主要结局
Frequency of postoperative complications, occuring up to 30 days post-operatively
时间窗: Day 30
次要结局
未报告次要终点