Mini- or Less-Open Sublay Operation (MILOS) - a New Minimally Invasive Technique for the Extraperitoneal Repair of Incisional Hernias
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 615
- 主要终点
- Reoperation after incisional hernia repair
研究概览
简要总结
Prospective non-randomized observational register study of all elective symptomatic incisional hernias operated on in the Hernia Center of Reference of Gross Sand Hospital using the novel endoscopic assisted Mini- or Less-Open Sublay technique. The data of all patients were prospectively documented in the German Hernia Registry "Herniamed". The novel MILOS-technique allows the minimal invasive implantation of large extraperitoneal meshes for the treatment of primary and secondary incisional hernias.
详细描述
Prospective non-randomized observational register study of all elective symptomatic incisional hernias operated on in the Reference Hernia Center of Gross Sand Hospital between 1 January 2010 and 30 September 2015 using the novel endoscopic assisted Mini- or Less-Open Sublay technique. The novel MILOS-technique allows the minimal invasive implantation of large extraperitoneal meshes for the treatment of primary and secondary incisional hernias.The data of all patients were prospectively documented in the German Hernia Registry "Herniamed". Data privacy protection was strictly implemented according to German federal law. All patients were informed in detail about the new surgical technique, other treatment options, prospective register study with one year questionnaire follow-up, data documentation. All patients gave written consent.
A propensity score matching of all patients of the MILOS-cohort of Gross Sand Hospital with patients with comparable incisional hernias who were operated on using the laparoscopic intraperitoneal onlay mesh (IPOM) technique or open sublay technique in other institutions participating in the German Hernia Database "Herniated" was performed.
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 patients with symptomatic elective primary or secondary incisional hernias:
- •Median incisional hernias
- •Lateral incisional hernias
排除标准
- •Emergencies
- •Very large incisional hernias that required incisions larger than 12 cm
结局指标
主要结局
Reoperation after incisional hernia repair
时间窗: one year follow-up
Data collected in German National Hernia Registry (Herniamed)
Recurrence after incisional hernia repair as assess by clinical examination at one year
时间窗: one year follow-up
Data collected in German National Hernia Registry (Herniamed)
Chronic pain after incisional hernia repair as reported by questionnaire and follow up examination at one year
时间窗: one year follow-up
Data collected in German National Hernia Registry (Herniamed)
Perioperative complications after incisional hernia repair
时间窗: one year follow-up
Data collected in German National Hernia Registry (Herniamed)
次要结局
未报告次要终点
研究者
Wolfgang Reinpold
Director of the Department of Surgery and Hernia Center Gross Sand Hospital
Gross Sand Hospital
