跳至主要内容
临床试验/NCT02564757
NCT02564757已完成不适用

Does Pregnancy Increase Risk of Ventral Hernia Recurrence?

Bispebjerg Hospital0 个研究点目标入组 3,578 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,578
主要终点
Clinical Ventral Hernia (Epigastric, Umbilical and Incisional Hernia) Recurrence

研究概览

简要总结

The investigators will examine if pregnancy increases risk of ventral hernia recurrence

详细描述

The investigators will establish a cohort of female fertile patients who underwent ventral hernia repair (Umbilical, Epigastric and Incisional hernia repair) registered in the Danish Hernia Database. The investigators will link these data at an individual level with the Danish National Patient Registry (DNPR), Danish Medical Birth Registry (DMBR) and the Danish Civil Registry (CPR).

From DMBR, subsequent pregnancies in the study cohort will be noted. From DNPR, ventral hernia recurrence, defined as clinical recurrence and/or reoperation for recurrence will be noted. Cases registered with both clinical recurrence and reoperation for recurrence, the date of the earliest registration will be defined as the date of ventral hernia recurrence.

From CPR, date of death or emigration will be noted.

Through an extended Cox regression analysis, handling pregnancy as a time-dependent variable, the investigators will examine whether pregnancy is associated with an increased risk of ventral hernia recurrence.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
12 Years 至 45 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Fertile female patient

排除标准

  • non-Danish citizen

结局指标

主要结局

Clinical Ventral Hernia (Epigastric, Umbilical and Incisional Hernia) Recurrence

时间窗: 0-7 years

Clinical ventral hernia recurrence will be defined as clinical recurrence retrieved from the Danish National Patient Registry.

Ventral Hernia (Epigastric, Umbilical and Incisional Hernia) Recurrence Repair

时间窗: 0-8 years

Ventral hernia recurrence repair will be defined as reoperation retrieved from the Danish National Patient Registry.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Erling Oma

Research scholar

Bispebjerg Hospital

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