Randomized Controlled Trial of Laparoscopic vs. Open Mesh Inguinal Hernia Repair in Men Under the Age of 60
试验速览
- 阶段
- 不适用
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Hernia recurrence rates at 2 years post surgery.
研究概览
简要总结
This study will determine whether laparoscopic and open hernia repair have the same recurrence and complication rates in the under 60yr old age group. The overall financial costs of each repair will also be compared.
详细描述
Study population is Waitemata Health (Auckland New Zealand) patients presenting to clinic with unilateral primary inguinal hernia aged less than 60 years, fit for surgery and able to consent for the study. Randomized to open mesh repair or laparoscopic preperitoneal mesh repair. Two surgeons (Dr Rodgers and Dr Hammodat) using a standardized technique. Conversion rates from lap to open will be recorded.
Phone assessment postop day 1, 1 week and at 6 months. Clinic assessment at 4 weeks, 1 year and 2 years.
Primary outcome is hernia recurrence which will be assessed by a research nurse independent of surgeon at each clinic appointment. Assessment to also include assessment of ongoing symptoms such as pain/discomfort, sensory disturbance, and sexual dysfunction.
Quality of life assessment (SF 36 questionnaire) preoperatively and at each assessment.
Pain assessment 4hrs postop and at all other assessments by score 0-10 and measurement of pain relief.
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
- 15 Years 至 60 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male <60yrs with primary inguinal hernia
排除标准
- •Recurrent hernia
- •Bilateral hernia
- •Non-reducible/obstructed hernia
- •Previous lower abdominal surgery/radiotherapy
结局指标
主要结局
Hernia recurrence rates at 2 years post surgery.
次要结局
- Length of hospital stay.
- Cost of equipment use.
- Rate of conversion to open procedure
- Duration of procedure.
- Complication rates.
- Time to return to work and usual activities.
- Pain scores and analgesic use.