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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06770647

Enrollment

96586

Registered

2025-01-13

Start date

2024-07-01

Completion date

2024-12-15

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retrospective Study

Keywords

mFI-5, Modified 5-Item Frailty Index, Breast conserving surgery

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?

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Germany

Outcome results