跳至主要内容
临床试验/NCT05920200
NCT05920200招募中不适用

Factors Affecting the Results of Treatment of Patients With Hernias of Various Localization: Evaluation of Treatment Results Using an Automated Hernia Register

Immanuel Kant Baltic Federal University1 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2020年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
4,000
试验地点
1
主要终点
Chronic postoperative pain rate and severity

研究概览

简要总结

The study attempts to quantify the relative risks for acute postoperative pain, complications rate, chronic postoperative pain (CPIP) and recurrence rate after different methods of repair of groin, umbilical and incisional hernia depending on surgical technique, mesh type and fixation suture material.

For this purpose the investigators will analyze data from the Kalinigrad Hernia Registry (KHR).

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All mesh and non-mesh repairs that have been registered in the KHR from January 9, 2020, until December 31, 2023.

排除标准

  • Patients not having a 11-digit state-assigned Personal insurance policy number.
  • Parastomal hernia;
  • infected hernias;

结局指标

主要结局

Chronic postoperative pain rate and severity

时间窗: 1 year

The painDETECT questionnaire will be used to identify chronic postoperative pain. Final painDETECT Score: 20, indicating that a neuropathic pain component is likely (\>90%).

Recurrence rate

时间窗: 3 year

the overall frequency of recurrent hernias

次要结局

  • Treatment satisfaction rate(3 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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