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临床试验/NCT06770647
NCT06770647已完成不适用

Predicting Outcomes of Breast-Conserving Surgery in Breast Cancer Patients Using the Modified 5-Item Frailty Index

Technical University of Munich1 个研究点 分布在 1 个国家目标入组 96,586 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
96,586
试验地点
1
主要终点
General data

研究概览

简要总结

Background: Breast cancer is the most common malignancy among women worldwide, with breast-conserving surgery (BCS) being a key treatment. The modified 5-item frailty index (mFI-5), a well-validated tool for assessing frailty, has shown predictive utility in other surgical contexts but remains under-explored in BCS.

Methods: Using the American College of Surgeons National Surgical Quality Improvement Program database (2008-2021), the investigators identified adult female breast cancer patients who underwent BCS. Frailty was assessed using the mFI-5, scored from 0 to 5, with higher scores indicating greater frailty. Multivariable logistic regression was employed to evaluate associations between mFI-5 scores and postoperative outcomes.

Main question: Can the mFI-5 predict adverse postoperative outcomes in breast-conserving surgery patients?

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

General data

时间窗: 30 days

* Hospital length of stay (in days). * Operative time (in minutes).

Any complications

时间窗: 30 days

* Patient mortality. * (Unplanned) readmission. * Surgical and/or medical complications.

Surgical Complications

时间窗: 30 days

* Infections (superficial, deep, or organ-space). * Wound dehiscence. * Bleeding requiring transfusion.

Medical Complications

时间窗: 30 days

* Pneumonia. * Reintubation. * Pulmonary embolism. * Ventilator dependence \>48 hours. * Progressive renal insufficiency. * Urinary tract infection. * Stroke or cerebrovascular accident. * Myocardial infarction. * Deep vein thrombosis or thrombophlebitis. * Sepsis. * Septic shock.

次要结局

未报告次要终点

研究者

发起方
Technical University of Munich
申办方类型
Other
责任方
Sponsor

研究点 (1)

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