跳至主要内容
临床试验/NCT03133000
NCT03133000已完成不适用

Mini- or Less-Open Sublay Operation (MILOS) - a New Minimally Invasive Technique for the Extraperitoneal Repair of Incisional Hernias

Gross Sand Hospital0 个研究点目标入组 615 人开始时间: 2010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
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

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

发起方
Gross Sand Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wolfgang Reinpold

Director of the Department of Surgery and Hernia Center Gross Sand Hospital

Gross Sand Hospital

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