NCT06008535已完成不适用
10-year Results of Open Inguinal Hernia Repair. A Prospective Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- Recurrence
研究概览
简要总结
The main goal of the research is to evaluate the long-term results of open anterior alloplasty of inguinal hernia, mainly the occurrence of recurrences. The secondary aim of the study is to clarify the incidence of chronic pain and foreign body sensation 10 years after inguinal hernia surgery.
Patients who meet the criteria for inclusion in the study are invited to an appointment, where a questionnaire is filled out, an clinical examination and an ultrasound examination are performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary inguinal hernia operated between 2008-2013 at the Tartu University Hospital
- •elective surgery
- •age at least 18 years old at the time of the operation
- •ability to understand the guidelines and willing to participate in the study
排除标准
- •recurrent hernia
- •strangulated hernia
- •age under 18 years at the time of surgery
- •does not agree to participate in the study
- •does not understand the guidelines. Regarding the last exclusion criterion: since it is an assessment of the remote results of the treatment and probably relatively many of the subjects are very elderly, it may happen that when contacting the patient by phone it turns out that the patient is no longer adequate to make a decision about participating in the study or to answer questions (experienced cerebral infarction, dementia, etc. .) - in this case, the patient is not invited to the appointment.
结局指标
主要结局
Recurrence
时间窗: at 10-year follow-up
Inguinal hernia recurrence on clinical examination or in ultrasound
次要结局
- Chronic pain(at 10-year follow-up)
研究者
Ceith Nikkolo
general surgeon
Tartu University Hospital
研究点 (1)
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