Clinical trial · Observational
Predicting Outcomes of Breast-Conserving Surgery in Breast Cancer Patients Using the Modified 5-Item Frailty Index
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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?
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Retrospective Study | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- General data
- timeFrame
- 30 days
- description
- * Hospital length of stay (in days). * Operative time (in minutes).
- measure
- Any complications
- timeFrame
- 30 days
- description
- * Patient mortality. * (Unplanned) readmission. * Surgical and/or medical complications.
- measure
- Surgical Complications
- timeFrame
- 30 days
- description
- * Infections (superficial, deep, or organ-space). * Wound dehiscence. * Bleeding requiring transfusion.
- measure
- Medical Complications
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available