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临床试验/NCT07621575
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:

  1. Daily drain output (measured in mL/day).
  2. Duration of the drain in place.
  3. Amount of seroma aspiration after the drain removal.
  4. Number of days till the last seroma aspiration.

Secondary Outcomes:

  1. Flap necrosis.
  2. 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

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

发起方
MOHAMED GAMAL AHMED ARAKEEB
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

MOHAMED GAMAL AHMED ARAKEEB

surgical oncology resident at Tanta cancer center

Kafrelsheikh University

研究点 (1)

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