NCT03721575已完成不适用
Scarpa Fascia Preservation Versus Removal During Hernio-abdominoplasty: a Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Volume of postoperative drainage
研究概览
简要总结
This randomized trial aimed to assess the efficacy of preservation of Scarpa's fascia during hernio-abdominoplasty in reducing the volume of postoperative drainage, accelerating time to drain removal and recovery, and reducing complication rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with complex ventral hernia that are fit for surgery (ASA class I and II) (Saklad, 1941).
- •Patients with class III, IV according to Pitanguy's classification of abdominal deformities (Pitanguy, 1995).
排除标准
- •Patient with ASA class III, IV, and V.
- •Morbid obesity (BMI > 40).
- •Recurrent incisional hernias after mesh hernioplasty.
- •Strangulated hernias.
- •Isolated small paraumbilical hernias.
- •Patients with abdominal organomegaly and/or ascites.
- •Patients with coagulopathy,
- •Patients who are heavy smokers, patients with pulmonary problems, and patients with uncontrolled diabetes.
研究组 & 干预措施
Scarpa's preserving hernio-abdominoplasty
Active Comparator
Hernio-abdominoplasty is performed with preservation of Scarpa's fascia.
干预措施: Scarpa's preserving hernio-abdominoplasty (Procedure)
Classical hernio-abdominoplasty
Active Comparator
Hernio-abdominoplasty is performed with removalof Scarpa's fascia.
干预措施: Classical hernio-abdominoplasty (Procedure)
结局指标
主要结局
Volume of postoperative drainage
时间窗: Two weeks after surgery
The volume of fluid drained through suction drains per 24 hours
次要结局
未报告次要终点
研究者
Sameh Emile
Lecturer of general surgery
Mansoura University
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