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

NCT ID: NCT06575049

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-01

Study Completion Date

2026-02-20

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MAXIGESIC

Maxigesig group

No interventions assigned to this group

Ketololac

ketololac group

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyeong-Gon Moon

PF.

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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JIN YOUNG BYEON

Role: CONTACT

0220721563

Other Identifiers

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2312-168-1498

Identifier Type: -

Identifier Source: org_study_id

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