Mesh and Mesh Fixation in Laparoscopic Groin Hernia Surgery: A Swedish Hernia Registry Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38,450
- 主要终点
- Death
研究概览
简要总结
The study attempts to quantify the relative risks for recurrence depending on complex combinations of plausible risk factors, in particular mesh, mesh fixation, hernia size and hernia type.
For this purpose the investigators will analyze data from the Swedish Hernia Registry (SHR).
详细描述
This is an open cohort study design where the investigators will analyze existing data that have been prospectively collected in the Swedish Hernia Registry (SHR), which covers > 95% of all groin hernia repairs in Sweden. The very large cohort of more than 38,000 TEP (totally extraperitoneal) and TAPP (transabdominal preperitoneal) repairs enables assessment of the relative risks for recurrence depending on complex combinations of plausible risk factors, in particular mesh, mesh fixation, hernia size and hernia type, with fulfilling statistical power.
Each participant was entered at the date of surgery, when demographic and intraoperative data were registered. Reoperations were registered in the SHR in the same manner as index repairs, and were used as endpoints.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All laparoscopic (mainly TEP and TAPP) repairs that have been registered in the SHR from January 1, 2005 until December 31, 2018.
排除标准
- •Open repairs.
- •Hernioplasties that were converted from laparoscopic to open surgery.
- •Age < 15 years.
- •Patients not having a 10-digit state-assigned Patient Identification Number.
结局指标
主要结局
Death
时间窗: Assessment at Dec 31, 2018
The date of death
Reoperation for recurrence
时间窗: Assessment at Dec 31, 2018
The date of the recurrent surgery
次要结局
未报告次要终点
研究者
Bengt Novik
Principal Investigator
Karolinska Institutet