Preoperative i.v. Iron Substitution in Patients With Colon Carcinoma and Iron-deficiency Anemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 514
- 试验地点
- 1
- 主要终点
- postoperative complications
研究概览
简要总结
About 70% of colon cancer patients are anemic. Preoperative anemia in patients with colorectal cancer is associated with both impaired disease-free survival and overall survival. The purpose of this study is to compare the effects of preoperative iv iron substitution on postoperative recovery in preoperatively anemic (male Hb <130, female Hb <120) and iron deficient colon cancer patients in a prospective setup. As a primary outcome, the effect of iv-iron substitution on postoperative complications is investigated.
详细描述
Randomized preoperative iron substitution for patient with iron deficient anemia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age> 18 years
- •Dg: Colon ca
- •The planned measure: the colon resection
- •Men: Hb <130, women: Hb <120 and iron deficiency (elevated TfR, low TrFesat or low ferritin)
排除标准
- •hyperreactivity for Ferinject
- •haemochromatosis
- •refusal for participation
研究组 & 干预措施
Iron arm
Half of patients get i.v. iron preoperatively
干预措施: Ferric carboxymaltose (Drug)
结局指标
主要结局
postoperative complications
时间窗: 30 days
At study, difference between arms will be evaluated: Complications are analysed using Clavien-Dindo classification https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1360123/bin/3TT1.jpg
次要结局
- Need for red blood cell transfusion(30 days)
研究者
Selja Koskensalo
Consultant, abdominal surgeon,Md, PhD
Helsinki University Central Hospital