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

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?

Study Overview

• Status: Completed
• Conditions: Retrospective Study

• Study Type: Observational
• Enrollment (Actual): 96586

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81675
      • Technische Universität München

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients with Breast conserving surgery without lymph node removal

Description

Inclusion Criteria

• Data from 14 annual datasets (2008-2021).
• Female breast cancer patients identified using diagnostic codes:
• ICD-9-CM 174: "Malignant neoplasm of female breast."
• ICD-9-CM 233.0: "Carcinoma in situ of breast."
• ICD-10-CM C50: "Malignant neoplasm of breast."
• ICD-10-CM D05: "Carcinoma in situ of breast."
• Focused on patients diagnosed with breast cancer.
• Further refinement:
• Only patients undergoing breast-conserving surgery (BCS).
• Identified by CPT code 19301: "Partial mastectomy without axillary lymphadenectomy."

Exclusion Criteria

• Missing essential anthropometric data (height and/or weight).
• Implausible BMI values (<7 kg/m² or >250 kg/m², assumed data entry errors).
• Miscoded or vague ICD or CPT entries.
• Concurrent invasive procedures other than BCS.
• Procedures performed by specialties other than general or plastic surgery.
• Male and non-binary patients or those with gender identity disorders (to focus on biologically female cohort).
• Non-elective (emergency) surgical cases.
• Patients with ASA physical status scores >4.
• Patients receiving anesthesia types other than general anesthesia.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Collaborators: Harvard Medical School (HMS and HSDM)
• Investigators: Study Chair: Adriana C Panayi, MD PhD, Division of Plastic Surgery, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): August 1, 2024
• Study Completion (Actual): December 15, 2024

Study Registration Dates

• First Submitted: December 22, 2024
• First Submitted That Met QC Criteria: January 7, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 7, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Breast conserving surgery; mFI-5; Modified 5-Item Frailty Index
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: 2013P001244

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No