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

NCT06770647 | Completed

• 1 other identifier: 2013P001244
• Study Type: observational
• Target: 96,586
• Locations: 1 country
• Sites: 1

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?

Conditions

Retrospective Study

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

Eligibility Criteria

• Gender Eligibility Details: Women with breast cancer
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients with Breast conserving surgery without lymph node removal

You may qualify if:

• 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."

You may not qualify if:

• 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.

Sponsors & Collaborators

• Technical University of Munich: lead
• Harvard Medical School (HMS and HSDM): collaborator

Study Sites (1)

Technische Universität München

Munich, Bavaria, 81675, Germany

Location

Study Officials

• Adriana C Panayi, MD PhD

  Division of Plastic Surgery, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: January 13, 2025
• Study Start: July 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: December 15, 2024
• Last Updated: January 13, 2025

Record last verified: 2025-01

Locations

DE (1)