NCT01018524已完成4 期
Results of Open Mesh Versus Suture Repair in Treatment of Abdominal Wall (Multicentric, Prospective, Randomised, Internet-based, Clinical Trial)
Hungarian Surgical Society2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2002年3月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- recurrence rate after hernia surgery
研究概览
简要总结
The purpose of this study is to:
- compare the long term results of mesh versus suture repair in treatment of abdominal wall defects;
- find the optimal location of implanted prosthesis, comparing the two most useful position of mesh in abdominal wall hernia surgery.
详细描述
To determine difference of operation time, applied materials of hernia operations; clinical complications, postoperative pain, hernia recurrence, recovery and normal activity time after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
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
- •During the two-year randomization period at the joined centres all patients were included who were admitted with abdominal wall or umbilical hernia and who suited the requirements.
- •All the patients with primer or first recurrence of postoperative abdominal or primer or first recurrence of umbilical hernia were randomized into this study.
- •For involvement into the study good patient compliance, signed consent form, normal local circumstances were needed.
排除标准
- •Ages fewer than 18 or above 70 years
- •Hernia orifice under 5 cm
- •Planned or accidental intraoperative opening of any bowel.
- •Unstable parameters of circulation, uncontrollable diabetic or autoimmune disease.
- •Severe renal or hepatic failure
- •Advanced stage of tumours or currently treated malignancies.
- •Inflamed or muddy content of hernia sac.
- •If the patient did not signed the consent form.
结局指标
主要结局
recurrence rate after hernia surgery
时间窗: 5 years
次要结局
- chronic pain after hernia surgery(more one year)
- complications after hernia surgery(0-5 years)
研究者
研究点 (2)
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