NCT06575049尚未招募不适用
Comparative Analysis of Seroma and Hematoma Rates: MAXIGESIC vs. Ketorolac in Breast Cancer Surgery Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- hematoma incidence
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
hematoma incidence
时间窗: within 3 months
hematoma incidence
Postoperative hemovac or JP total drainage amount
时间窗: within 3 months
Postoperative hemovac or JP total drainage amount
Seroma incidence
时间窗: within 3 months
Seroma incidence
次要结局
- Length of hospital stay(within 3 months)
- Complication(within 3 months)
研究者
Hyeong-Gon Moon
PF.
Seoul National University Hospital
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