Nationwide Long-term Outcome Surveillance of Physiomesh® vs. Other Meshes in Laparoscopic Incisional Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,338
- 试验地点
- 2
- 主要终点
- Re-operation for recurrence rate
研究概览
简要总结
The primary aim of the present study was to show how a national clinical register combined with other nationwide administrative registers may serve as a tool for pre- and post-marketing evaluation of new mesh and mesh fixation products for hernia surgery, using Physiomesh® versus other meshes designed for laparoscopic hernia repair as an example.
详细描述
All adult (≥18 yrs) patients registered in the Danish Hernia Database (DHB) who underwent elective primary laparoscopic incisional hernia repair between January 1st 2010 and December 31st 2016.
To obtain 100% follow-up data from DHB will be combined with administrative data from the Danish National Patient register.
Patients will be followed from initial hernia repair until reoperation for recurrence, death, emigration outside Denmark or end of follow-up (november 2017).
Physiomesh and other mesh repairs will be propensity score matched. Each patient in the Physiomesh® group will be matched with two patients treated with one of the other synthetic meshes. The Propensity score includes age, sex, year of surgery, diagnosis of chronic obstructive pulmonary disease, diagnosis of diabetes, diagnosis of obesity, Charlson comorbidity index and size of hernia defect
The primary outcome: Difference in risk for a reoperation for recurrence between patients operated with Physiomesh® and patients operated with another synthetic mesh designed for laparoscopic repair.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients registered in the Danish Hernia Database for a laparoscopic incisional hernia repair
排除标准
- •If not registered for a laparoscopic incisional hernia repair in the Danish Hernia Database
研究组 & 干预措施
Physiomesh
Patients undergoing laparoscopic incisional hernia repair reinforced with a Physiomesh.
干预措施: Physiomesh (Device)
other mesh
Patients undergoing laparoscopic incisional hernia repair reinforced with other meshes than Physiomesh.
结局指标
主要结局
Re-operation for recurrence rate
时间窗: up to 84 months
次要结局
- 30-reoperation for complication rate(30 day)
- 30-day readmission rate(30 day)
研究者
Frederik Helgstrand
Principal Investigator
Zealand University Hospital