NCT05929378已完成不适用
A Comparative Study of 3-point With 1-point Mesh Fixation in TAPP Surgery for Patients With Gilbert Type III Inguinal Hernia: A Randomized Controlled Trial
Nanchong Central Hospital1 个研究点 分布在 1 个国家目标入组 351 人开始时间: 2023年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 351
- 试验地点
- 1
- 主要终点
- recurrence
研究概览
简要总结
This study was designed to compare the outcome of 3 point with 1 point lightweight mesh fixation in TAPP surgery for patients with type Ⅲ gilbert inguinal hernia. The main outcome include seroma, chronic pain, recurrence, et al.
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
- •Unilateral indirect inguinal hernia according to preoperative physical examination and imaging examination.
- •The inclusion criteria were as follows: primary indirect inguinal hernia classified as Gilbert III (defect size diameter ≥3cm, including scrotal hernias)
排除标准
- •Age below 18 years or older than
- •Direct hernia, femoral hernia, 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
recurrence
时间窗: 6 months
Check for recurrence by clinical examination or ultrasound at 6 months postoperatively
Postoperative pain
时间窗: 6 months
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
- postoperative complications(6 months)
研究者
Yunhong Tian
Director of Gastrointestinal, Colorectal and Hernia Surgery
Nanchong Central Hospital
研究点 (1)
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