NCT02723045Unknown不适用
The Comparison of the Quality of Life and Outcomes in Patient's With Reducible Inguinal Hernias: Laparoscopic Totally Extra-peritoneal (TEP) Versus Modified Lichtenstein Hernioplasty
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Quality of life
研究概览
简要总结
To determine if there is a difference in the quality of life in between patients who undergoes laparoscopic totally extra-peritoneal (TEP) or modified Lichtenstein hernioplasty
详细描述
Patients presenting with reducible inguinal hernias will be randomized between open or laparoscopic repair groups. The primary outcome will be the quality of life scores. Patients will be followed-up for 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •18 years of age and older
- •Both genders
- •Unilateral inguinal hernias
- •Reducible inguinal hernias
- •Elective setting
排除标准
- •ASA Physical Status (American Society of Anaesthesiologists) Grade > 2
- •Recurrence
- •Inguinal-scrotal hernias
- •Prostatectomy, Pfannenstiel incision, previous pre-peritoneal surgery
- •Pregnancy
- •Refusal for general anaesthesia
研究组 & 干预措施
Open modified Lichtenstein repair
Active Comparator
Patients will undergo open repair of their inguinal hernias
干预措施: Open Lichtenstein Hernioplasty (Procedure)
Laparoscopic TEP inguinal hernia repair
Active Comparator
Patients will undergo laparoscopic repair of their inguinal hernias
干预措施: Laparoscopic TEP Hernioplasty (Procedure)
结局指标
主要结局
Quality of life
时间窗: 12 months
Carolina Comfort Scale
次要结局
- Operating time(12 months)
- Complications(12 monthts)
- Duration of hospitalization(12 months)
- Recurrence(12 months)
研究者
Siow Sze Li
General Surgeon
Sarawak General Hospital
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