The Change in RetHe - Levels Perioperatively in a Cohort of Colorectal Surgery Patient: it's Role in Perioperative Hemoglobin Optimization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Change of RetHe measurement
研究概览
简要总结
During a period of a year, reticulocyte hemoglobin content (RetHe) measurements (Sysmex) are done out of blood samples taken on several occasions during normal patient care:
- preoperatively at the surgical or anesthetic outpatient visit
- on admission or pre- induction of anesthesia
- postoperatively at the postanesthetic care unit
- on day 3 postoperatively
- on day 5 postoperatively
Additionally a Quality of Life (QoL) questionnaire will be taken from the participants before surgery and 30 days after surgery to evaluate the course of QoL perioperatively.
详细描述
Study design An explorative, prospective cohort study of patients undergoing colorectal surgery in the Maastricht University Medical Center (MUMC) with a follow-up time of 30 days postoperatively.
A quality of life questionnaire (EQ-5D) will be administered on admission and 30 days postoperatively.
Origin of data Medical file of patients (SAP, PDMS) Database Study data are anonymous information, which cannot be tracked to the patient according to wet bescherming persoonsgegevens (WBP) and wet op geneeskundige behandelingsovereenkomst (WGBO). These will be stored at Castor Electronic Data Capture (EDC), secure online data collection for medical research), that embraces Good Clinical Practice (GPC) guidelines. For the analysis, anonymized data will be exported to Statistical Package for the Social Sciences (SPSS).
Preoperative anemia in the colorectal surgical population is a common and independent risk factor of perioperative morbidity and mortality. The detection, diagnostic and treatment of anemia are therefore a multidisciplinary obligation in the optimization of patient care.
In the perioperative setting anemia can be divided into three categories:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •All adult patients (≥ 18 years) scheduled for colorectal surgical operations (laparoscopic and open procedures)
排除标准
- •emergency surgery
- •minors and incapacitated
结局指标
主要结局
Change of RetHe measurement
时间窗: From baseline to 60 days postoperatively
To assess the change of RetHe measurement from baseline (preoperative assessment) to different points in time in standard care (i.e. RetHe measurement at day of admission, direct postoperatively and day 3 and 5 postoperatively)
次要结局
- Perioperative complications(Days of admission)
- Relation of RetHe to standard iron status measurements(1 year)
- Quality of life measurement preoperatively and 30-days postoperatively(From baseline to 30-days postoperatively)