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

Not yet recruiting

• Conditions: Post-Operative Hematoma; Post-Op Complication; Breast Cancer; Seroma as Procedural Complication

• Registration Number: NCT06575049
• Lead Sponsor: Seoul National University Hospital

Brief Summary

We 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. We 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-26
• Study First Submitted QC: 2024-08-26
• Last Update Submitted: 2024-08-26
• Study First Posted: 2024-08-28
• Last Update Posted: 2024-08-28
• Study Start: 2025-05-01
• Primary Completion: 2025-08-30
• Study Completion: 2026-02-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative hemovac or JP total drainage amount	within 3 months	Postoperative hemovac or JP total drainage amount
Seroma incidence	within 3 months	Seroma incidence
hematoma incidence	within 3 months	hematoma incidence

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	within 3 months	Length of hospital stay and re operation rate
Complication	within 3 months	* 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