Usefulness of Bioelectrical Impedance Analysis for Perioperative Fluid Evaluation and Complication Prediction in Oncological Patients Undergoing Colorectal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Postoperative Complications Within 30 Days After Colorectal Surgery
研究概览
简要总结
This study evaluates the usefulness of bioelectrical impedance analysis (BIA) for perioperative fluid evaluation and prediction of postoperative complications in oncological patients undergoing colorectal surgery.
Bioelectrical impedance analysis is used to assess body fluid status and body composition before and after surgery. The study aims to determine whether perioperative BIA measurements may contribute to improved assessment of fluid balance and early identification of patients at increased risk of postoperative complications.
The study is conducted at the Institute of Oncology Ljubljana in patients undergoing colorectal surgery for oncological indications.
详细描述
Accurate perioperative fluid assessment is important in patients undergoing colorectal surgery, as both fluid overload and inadequate fluid replacement may contribute to postoperative complications and delayed recovery.
Bioelectrical impedance analysis (BIA) is a non-invasive diagnostic method that enables assessment of body composition and fluid status. In this study, BIA measurements are performed in oncological patients undergoing colorectal surgery in order to evaluate perioperative changes in body fluid compartments and to assess whether these measurements may help predict postoperative complications.
The study evaluates the relationship between perioperative BIA parameters and clinical outcomes after colorectal surgery. The aim is to assess whether BIA may be useful as an additional diagnostic method for perioperative fluid evaluation and early identification of patients at increased risk of complications.
The study is conducted at the Institute of Oncology Ljubljana. According to the latest annual report, patient enrollment has been completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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 patients aged 18 years or older.
- •Patients with oncological disease undergoing colorectal surgery at the Institute of Oncology Ljubljana.
- •Ability to undergo bioelectrical impedance analysis (BIA) measurements.
- •Signed written informed consent.
排除标准
- •Patients younger than 18 years.
- •Patients unable to undergo BIA measurements.
- •Patients with conditions that, in the investigator's opinion, make participation in the study unsuitable.
- •Refusal to participate in the study.
结局指标
主要结局
Percentage of Participants With Postoperative Complications Within 30 Days After Colorectal Surgery
时间窗: Up to 30 days after colorectal surgery.
Postoperative complications will be identified from routine clinical documentation after colorectal surgery. The unit of measure will be the percentage of participants with at least one postoperative complication within 30 days after colorectal surgery.
Overall Survival
时间窗: Up to 5 years
Overall survival is defined as the time from study enrollment to death from any cause
次要结局
- Change From Baseline in Total Body Water Assessed by Bioelectrical Impedance Analysis(From preoperative baseline to postoperative assessment, up to 30 days after colorectal surgery.)
- Change From Baseline in Extracellular Water Assessed by Bioelectrical Impedance Analysis(From preoperative baseline to postoperative assessment, up to 30 days after colorectal surgery.)
- Change From Baseline in Intracellular Water Assessed by Bioelectrical Impedance Analysis(From preoperative baseline to postoperative assessment, up to 30 days after colorectal surgery.)
- Change From Baseline in Extracellular Water to Total Body Water Ratio Assessed by Bioelectrical Impedance Analysis(From preoperative baseline to postoperative assessment, up to 30 days after colorectal surgery.)
- Change From Baseline in Fat-Free Mass Assessed by Bioelectrical Impedance Analysis(From preoperative baseline to postoperative assessment, up to 30 days after colorectal surgery.)