NCT04516031Unknown不适用
Posterior Component Separation With Transversus Abdominis Muscle Release Versus Mesh Only Repair in the Treatment of Complex Ventral Wall Hernia: A Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Hernia recurrence
研究概览
简要总结
This trial was designed as a prospective randomized, controlled, intervention, with two parallel groups, and a primary endpoint of recurrence during 12 months' follow-up after initial treatment, with the randomization, was performed by an online software a 1:1 allocation.
详细描述
Eligibility Criteria
- both sexes
- aged between 18 and 65 years old
- presented complex ventral wall hernia or incisional hernia
Exclusion
- pregnant
- patients on steroid therapy
- underwent their hernia repair on an emergency basis
Interventions
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with complex ventral-wall and incisional hernia
排除标准
- •pregnant female
- •steroid therapy
- •emergency basis
结局指标
主要结局
Hernia recurrence
时间窗: after 12 months
Reappearance of symptoms or swelling
次要结局
- Mortality(30 days postoperative)
- Morbidity(30 days postoperative)
研究者
Mostafa shalaby, MD, MSc, PhD
Co-supervisor
Mansoura University
研究点 (2)
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