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

Completed

• Conditions: Retrospective Study

• Registration Number: NCT06770647
• Lead Sponsor: Technical University of Munich

Brief Summary

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-01
• Primary Completion: 2024-08-01
• Study Completion: 2024-12-15
• Study First Submitted: 2024-12-22
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-07
• Last Update Submitted: 2025-01-07
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 96586

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
General data	30 days	* Hospital length of stay (in days).; * Operative time (in minutes).
Any complications	30 days	* Patient mortality.; * (Unplanned) readmission.; * Surgical and/or medical complications.
Surgical Complications	30 days	* Infections (superficial, deep, or organ-space).; * Wound dehiscence.; * Bleeding requiring transfusion.
Medical Complications	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.

Trial Locations

Locations (1)

Technische Universität München; 🇩🇪 Munich, Bavaria, Germany