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Not yet recruiting NCT06575049

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Breast Cancer, Post-Operative Hematoma, Seroma as Procedural Complication, Post-Op Complication. Basic parameters: 20 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparative Analysis of Seroma and Hematoma Rates: MAXIGESIC vs. Ketorolac in Breast Cancer Surgery Patients

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.

Primary outcome measures

  • 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 outcome measures (2)
  • Length of hospital stay [Time frame: within 3 months]
  • Complication [Time frame: within 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06575049 · 2312-168-1498

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗