Iron Prehabilitation and Perioperative Infectious Diseases of Endometrial Cancer Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Number of participants with surgical site infection
研究概览
简要总结
Endometrial cancer patients often have iron deficiency anemia before surgery, which can be effectively treated with oral iron supplementation. Anemia and blood transfusions have been previously associated with perioperative infectious diseases. In the present study the investigators will evaluate the impact of perioperative iron supplementation on the incidence of perioperative infections.
详细描述
Prehabilitation has a multimodal conception based on three fundamental pillars: improvement of the patient's physical condition, nutritional optimization and other measures such as smoking cessation and correction of anemia.
As in the case of multimodal rehabilitation protocols, the actions of prehabilitation programs have synergistic effects, that is, small changes that, by themselves, do not have clinical significance but when added up, they produce a significant improvement in the postoperative evolution of patients.
Surgical site infections (SSIs) are considered to be the most common nosocomial infections among surgical patients and constitute a heavy and potentially preventable economic burden on health care providers. Although the impact of blood transfusion on the risk of SSI remains controversial, several studies have shown that anemia and transfusion predispose to postoperative bacterial infections.
In the present study the investigators seek to evaluate the impact of per os iron prehabilitation on perioperative outcomes of endometrial cancer patients, including need for transfusion and infectious morbidity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 79 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with endometrial cancer enrolled in the surgical list
排除标准
- •Women with endometrial cancer requiring immediate surgery due to life-threatening hemorrhage
研究组 & 干预措施
Iron supplementation
Iron supplementation will be provided in the form of ferrous gluconate 300mg twice a day for a period of 1 month
干预措施: Ferrous Gluconate 300 MG (Drug)
结局指标
主要结局
Number of participants with surgical site infection
时间窗: Postoperatively (up to 30 days)
Participants will be followed-up to determine the incidence of postoperative surgical site infection
Required blood transfusions per participant and aggregated mean differences
时间窗: Perioperatively (up to 10 days)
The number of perioperative (intraoperative and postoperative) blood transfusions per patient will be monitored and compared among the two groups.
次要结局
- Number of participants with other postoperative infections(Postoperatively (up to 30 days))
- Onset of adjuvant treatment per participant(Postoperatively up to 24 weeks)
- Duration of hospitalization per participant(Postoperatively (until patient exit) up to 30 days)
- Survival rates of included participants(Postoperatively (at 3 years postoperatively))
研究者
Nikolaos Thomakos
Associate Professor of Obstetrics and Gynecology
National and Kapodistrian University of Athens