Robotic Versus Conventional Minimal-invasive Inguinal Hernia Repair - a Prospective, Randomized and Blinded Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 182
- 试验地点
- 2
- 主要终点
- Pain 24 hours post surgery measured on a numeric rating scale (NRS 0-10)
研究概览
简要总结
Minimal invasive techniques have become a well established approach for inguinal hernia repair over the last decade in developed countries. Different techniques such as total extraperitoneal endoscopic hernioplasty (TEP) and transabdominal preperitoneal hernia repair (TAPP) have been described. These studies show comparable results in short and long term outcome. Robotic inguinal hernia surgery enables an even more precise dissection within the preperitoneal layer thus preserving the nerves of the lateral abdominal wall. This may translate into a reduced level of acute and chronic postoperative pain as previously reported by retrospective case series. The role of robotic surgery for inguinal hernia repair in regard of postoperative pain and recovery has not been investigated in randomized and blinded clinical studies yet. With this randomized and blinded trial the investigators compare robotic TAPP (rTAPP) to conventional TEP with a decreased pain level shortly after surgery as primary outcome (numeric rating scale - NRS). A reduced postoperative NRS for pain may translate into faster recovery and less chronic pain, secondary endpoints include comparison of pain in a longer course (short-form inguinal pain questionnaire (sf-IPQ)), quality of life / health status (Baseline Short Form-12 (SF-12), Carolinas Comfort Scale (CCS)), complications (Comprehensive Complication Index - CCI), rate of recurrence, , economic impact in terms of costs of surgery per patient, for the institution, the sick leave and the cost-effectiveness of health intervention (SF-6D, EQ-5D, ICECAP-O). Also included are ergonomics for the surgeon (NASA TLX).
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
- Double (Participant, Outcomes Assessor)
盲法说明
patient and assessor blinded study
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
- •Patients older than 18 years of age and able to understand and give their informed consent for the study.
- •Primary unilateral or bilateral hernia
排除标准
- •Recurrent hernia
- •with previous open abdominal surgery at or below the umbilicus
- •need of an open inguinal hernia repair (patient's preference, unable to undergo general anesthesia, unable to tolerate pneumoperitoneum)
- •liver disease defined by the presence of ascites
- •end-stage renal disease requiring dialysis
- •unable to give informed consent
- •need of an emergency surgery
- •pregnancy
结局指标
主要结局
Pain 24 hours post surgery measured on a numeric rating scale (NRS 0-10)
时间窗: 24 hours
Pain at coughing 24 hours after surgery measured on a numeric rating scale (NRS 0-10) while coughing
次要结局
- Pain 30 days post surgery measured on a numeric rating scale (NRS 0-10)(30 days)
- ICECAP-O (ICEpop CAPability measure for Older people) questionnaire(24hours, 7 and 30 days, 6 and 12 months)
- Time in the OR block(During surgery)
- Time measured in days patients are hospitalized after surgery(7 days)
- Ergonomics for the surgeon(1 day)
- Pain 7 days post surgery measured on a numeric rating scale (NRS 0-10)(7 days)
- Intraoperative complications(During surgery)
- Pain medication postoperative(12 months)
- SF-6D (Short Form - Dimension) questionnaire(24hours, 7 and 30 days, 6 and 12 months)
- Procedure time(During surgery)
- EQ-5D-5L (European Quality of Life - 5 Dimension - 5 Level) questionnaire(24hours, 7 and 30 days, 6 and 12 months)
- Name and Dosage of pain medication intraoperativ(During surgery)
- Time measured in hours patients are in the outpatient clinic until discharge(24 hours)
- Postoperative morbidity(30 days)
- Costs per patients(30 days)
- Sick leave(12 months)
- Costs for sick leave(12 months)
- Pain 2 hours post surgery measured on a numeric rating scale (NRS 0-10)(2 hours)
- Recurrence rate(12 months)
- SF-12 (Short Form)(12 months)
- Carolinas Comfort Scale (CCS)(12 months)
- Type of labor including the relative activity level(1 day)