NCT06879860Enrolling By Invitation不适用
The Effects of 3D Patch Fixation With One Suture Versus no Fixation on Chronic Pain and Recurrence in Patients With Ⅲ Type Inguinal Hernia: A Multicenter Randomized Controlled Trial
Nanchong Central Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Rate of recurrence
研究概览
简要总结
This study aims to compare the effects of one-stitch fixation and non-fixation of 3D patches on chronic pain and recurrence in type III inguinal hernia. The primary outcome measures include hernia recurrence, chronic pain, etc.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary inguinal hernia
- •Type III inguinal hernia (internal annulus >3cm)
排除标准
- •Age below 18 years or older than
- •recurrent hernia, incarcerated hernia,strangulated hernia, and other types of hernias.
- •Patients not suitable for general anesthesia.
- •Patients requiring open surgery.
- •patients requiring emergency surgery Loss to follow-up or communication difficulties, or poor compliance.
结局指标
主要结局
Rate of recurrence
时间窗: 1 month,3 months,6 months and 12 months after surgery
Hernia recurrence Follow up by physical examination, ultrasonography and telephone at 1 month,3 months,6 months and 12 months after surgery about the rate of hernia recurrence.
Rate of postoperative pain
时间窗: 6 month
The visual analog scale (VAS) was adopted for pain evaluation 2 days, 3 months, and 6 months postoperatively. The scale range from 0 to 10, with 0 meaning no pain and 10 meaning the worst pain.
次要结局
- Rate of postoperative complications(6 month)
研究者
研究点 (1)
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