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
- Postoperative hemovac or JP total drainage amount
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
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
hematoma incidence
时间窗: within 3 months
hematoma 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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