The Efficacy of a Self-fixating Mesh in Unilateral Open Inguinal Hernia Repair, in Comparison to the Standard Treatment in the Literature
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Percentage of post operative inguinal Hernia recurrence.
研究概览
简要总结
This study's objective is to assess the efficacy of a Self-fixating mesh in the surgical repair of unilateral inguinal hernia, which is becoming the new standard of care in open surgical repair of inguinal hernia.
The study design is interventional, enrolling 300 patients above 18 years of age, admitted for elective repair in the surgical department of Rambam Medical Health Care Campus, an academic medical center.
The study will assess several outcomes including post-surgical pain, recurrence, quality of life and post surgical complications (e.g. wound infection, the formation of hematoma or seroma, etc).
详细描述
This study's objective is to assess the efficacy of a Self-fixating mesh in the surgical repair of unilateral inguinal hernia, which is becoming the new standard of care in open surgical repair of inguinal hernia.
The study design is interventional, enrolling 300 patients above 18 years of age, admitted for elective repair in the surgical department of Rambam Medical Health Care Campus, an academic medical center.
The study will assess several outcomes including post-surgical pain, recurrence, quality of life and post surgical complications (e.g. wound infection, the formation of hematoma or seroma, etc).
The data will be compared to the literature and will be statistically analysed. The follow-up for each patient will be two years.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing primary unilateral open Inguinal Hernia Repair .
- •patients undergoing elective surgery.
- •above the age of 18 years old
排除标准
- •patients having repeated Inguinal Hernia.
- •patients having bilateral Hernia.
- •patients undergoing laparoscopic surgery.
- •patients undergoing non-elective surgery.
结局指标
主要结局
Percentage of post operative inguinal Hernia recurrence.
时间窗: 2 weeks, 3,6,12,24 months post-operative
Post-operative patient quality of life will be assessed using a validated questionnaire.
时间窗: 2 weeks, 3,6,12,24 months post-operative
Pain will be assessed by NRS (Numerical Rating Scale)
时间窗: 2 weeks, 3,6,12,24 months post-operative
Post-operative complications will be assessed using a validated questionnaire.
时间窗: 2 weeks, 3,6,12,24 months post-operative
次要结局
未报告次要终点