Short-term Outcome and Inflammatory Stress Response Following Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP) - A Prospective, Randomized Trial Comparing Laparoscopy to the Robotic-assisted Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Surgical stress response (CRP)
研究概览
简要总结
The present study seeks to determine whether improved visual acuity and enhanced flexibility of the robotic platform results in a reduced surgical stress response and an improvement in indices of surgical outcome measures for simple and complex inguinal hernia repair
详细描述
Complex inguinal hernia repair is challenging and requires both advanced skills in laparoscopic surgery and knowledge about the complex anatomy of the inguinal area. Whereas the repair of a small inguinal hernia usually is simple and straightforward, complex hernias (large inguinoscrotal and recurrent hernias) constitute a surgical challenge due to the risk of damage of the neurovascular structures in the inguinal area. It requires advanced laparoscopic skills to reduce the hernial sac in patients with large lateral hernias, where the hernial sac often extends deep into the scrotum in close vicinity to the spermatic cord and the testicular artery. This dissection is difficult with conventional laparoscopy, which may explain the risk of chronic pain, testicular hypotrophy and hernia recurrence. The aim of the study is to determine whether rTAPP of complex inguinal hernias is associated with a lower surgical stress response and a lower risk of postoperative complications compared to laparoscopic TAPP.
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
- •Clinical or radiologic diagnosis of inguinal hernia (unilateral, bilateral, recurrent, inguinoscrotal)
- •Eligible for a laparoscopic procedure
- •Informed concent
排除标准
- •Incarcerated inguinal hernia requiring emergency surgery
- •Pregnancy
- •Patients with chronic pain due to arthritis, migraine or other illness requiring regular intake of pain relieve (paracetamol, NSAID etc)
- •Active cancer
- •History of psychiatric or additive disorder that prevent the patient from participating in the trial
- •Co-existing inflammatory disease
- •Co-existing immunological disease that requires medication of any kind
研究组 & 干预措施
Robotic TAPP
Repair of primary unilateral and bilateral hernias with robotic technology
干预措施: Robotic TAPP (Procedure)
Laparoscopic TAPP
Repair of primary unilateral and bilateral hernias with laparoscopic repair
干预措施: Laparoscopic TAPP (Procedure)
结局指标
主要结局
Surgical stress response (CRP)
时间窗: CRP will be measured preoperatively at baseline, 1 day postoperatively and 3 days postoperatively
Change of serum CRP over time.
次要结局
- Surgical stress response (IL1-β)(IL1-β will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation)
- Surgical stress response (IL-10)(IL-10 will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation)
- Length of hospital stay(Up to 3 months)
- Estimated intraoperative blood loss(intraoperative (From first incision until last suture has been placed))
- Total surgical time(During surgery)
- Postoperative complications(From surgery until 6 months postoperatively)
- Life-quality(From inclusion until 6 months postoperatively)
- Surgical stress response (IL-6)(IL-6 will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation)
- Surgical stress response (IL-8)(IL-8 will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation)
- Sexual dysfunction(From inclusion until 6 months postoperatively)
- Intraoperative need of blood transfusion(intraoperative (From first incision until last suture has been placed))
- Surgical stress response (TNF-α)(TNF-α will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation)
- Hernia defect size(During surgery)