NCT07621575已完成不适用
Comparison Between Active Drainage And Passive Drainage In Post-Operative Seroma Formation After Modified Radical Mastectomy In Female Patients With Breast Carcinoma: A Prospective Randomized Controlled Trial.
MOHAMED GAMAL AHMED ARAKEEB1 个研究点 分布在 1 个国家目标入组 157 人开始时间: 2024年5月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 157
- 试验地点
- 1
研究概览
简要总结
The aim of the study is to compare between active drainage and passive drainage in post-operative seroma formation after modified radical mastectomy in female patient with breast carcinoma as regard of:
Primary Outcomes:
- Daily drain output (measured in mL/day).
- Duration of the drain in place.
- Amount of seroma aspiration after the drain removal.
- Number of days till the last seroma aspiration.
Secondary Outcomes:
- Flap necrosis.
- Surgical site infection. 100 female divided into two equal groups:
- Group A: Active drainage group (50 patients).
- Group B: Passive drainage group (50 patients). After MRM ,drain output was measured daily using a graduated jar by nurse during hospital stay which was a one to two days in an average and then by patient himself. All the data was recorded on a paper sheet. In passive drain, breast and axilla outcomes were combined together as one read to be equal to one active drain gar. Twice per week, I checked this reading by myself and reported any complications).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patient diagnosed with breast carcinoma planned for MRM
排除标准
- •• Previous breast surgery.
- •Active infection.
- •Recurrent or metastatic breast cancer (Stage IV).
- •Un-controlled diabetes mellitus (HbA1C >7).
- •Coagulopathy disease.
- •Use of anticoagulant or antiplatelet medications.
- •Bilateral breast cancer.
- •Loss to follow-up within one month of drain removal.
- •Pregnancy.
- •Male breast cancer patients.
研究者
MOHAMED GAMAL AHMED ARAKEEB
surgical oncology resident at Tanta cancer center
Kafrelsheikh University
研究点 (1)
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