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临床试验/NCT03155230
NCT03155230已完成不适用

Nationwide Results on Chronic Pain After Bilateral Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP)

Hvidovre University Hospital1 个研究点 分布在 1 个国家目标入组 209 人开始时间: 2015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
入组人数
209
试验地点
1
主要终点
Activities Assessment Scale Questionnaire

研究概览

简要总结

Danish male patients who had undergone bilateral TAPP (July 2012 to June 2013) were recruited from the Danish Hernia Database and cross-checked with hospital files and the National Patient Registry. A standardized postal questionnaire was sent out two years after the index surgery to investigate Patients Related Outcome Measures (PROMs) such as chronic post-operative pain.

详细描述

The present study was primarily undertaken to provide evidence for the risk of activity-related chronic postoperative inguinal pain following bilateral TAPP in an all-male Danish setting. Impaired sexual activity and sleep disturbance due to pain was also recorded. Data based on nationwide consecutive patients undergoing bilateral TAPP. Data collected for the Danish Inguinal Hernia Database, hospital files and the National Patient Registry (Denmark).

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
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Danish males,
  • Age>18 years
  • Elective, bilateral TAPP due to inguinal hernia within the period from July 1, 2012 to June 30 2013

排除标准

  • age <18 years
  • miss-classified surgical code
  • non-Danish speaking
  • psychiatric anamneses
  • regarded and non-compliant patients who had either died, emigrated or were lost to follow-up emergency repair
  • femoral hernia repair

结局指标

主要结局

Activities Assessment Scale Questionnaire

时间窗: Within one week

Impaired daily activities by chronic pain from either one or both groin areas

次要结局

  • Questionnaire about sleep impairment(Within three months)
  • Questionnaire about sexual impairment(Within three months)

研究者

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

Niels Johansen

Principal Investigator

Hvidovre University Hospital

研究点 (1)

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