Seroma and Hematoma Rates: MAXIGESIC IV vs. Ketorolac in Breast Cancer Surgery

N/ANot Yet RecruitingNCT06575049

Seoul National University Hospital60 enrolled

Overview

The investigators aim to compare the incidence rates of seroma (fluid collection) and hematoma (blood clot) following breast cancer surgery between the conventional non-steroidal anti-inflammatory drug (NSAID) Ketorolac and MAXIGESIC. The investigators seek to determine the complication rates in patients receiving MAXIGESIC post-surgery, hypothesizing that the higher dosage of ibuprofen in MAXIGESIC compared to Ketorolac will result in lower complication rates.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Breast Cancer Post-Operative Hematoma Seroma as Procedural Complication Post-Op Complication

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Systemic performance status 0-2 according to ECOG criteria * Patients with adequate renal function: serum Cr 1.4 mg/dL or less * Patients with adequate liver function Bilirubin, AST/ALT: 1.5 times or less of the upper limit of normal, Alkaline phosphatase: 1.8 times or less of the upper limit of normal * Patients undergoing total mastectomy with SLNB or ALND (mastectomy and axillary sentinel lymph node dissection) * Patients undergoing breast-conserving surgery with ALND (mastectomy and axillary dissection) * Patients who voluntarily decided to participate in this study and signed a written informed consent form Exclusion Criteria: * Patients undergoing immediate reconstruction operation * Patients with drug allergies to painkillers and anti-inflammatory drugs * Patients with a physical condition that would interfere with understanding and submitting the consent form

Outcomes

Primary Outcomes

Postoperative hemovac or JP total drainage amount

Time frame: within 3 months

hematoma incidence

Time frame: within 3 months

Seroma incidence

Time frame: within 3 months

Secondary Outcomes

Length of hospital stay

Length of hospital stay and re operation rate

Time frame: within 3 months

Complication

* When hematoma occurs: Whether transfusion is required and whether EB band is applied, check the amount when aspirating (diagnosis criteria color: sanguinous, old bloody \[brownish\], operation (hematoma evacuation) * When seroma occurs: check the amount when aspirating (diagnosis criteria color: serous, serosanguinous) * Complication: Whether abscess occurs

Time frame: within 3 months

Seroma and Hematoma Rates: MAXIGESIC IV vs. Ketorolac in Breast Cancer Surgery

Overview

Conditions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts