Robotic Assisted vs. Laparoscopic Hybrid IPOM Ventral Hernia Repair: a Prospective Randomized Study Comparing Postoperative Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Robotic-assisted ventral hernia repair vs hybrid. Change in pain
研究概览
简要总结
Laparoscopic ventral hernia repair (LVHR) may be associated with chronic pain, seroma formation, bulging and failure to restore abdominal wall function. These outcomes are risk factors for hernia recurrence and poor quality of life (QoL). Our study evaluates whether robotic-assisted ventral hernia repair (rVHR) diminish these complications compared to LVHR with primary closure of the defect (hybrid).
详细描述
Thirty patients undergoing incisional ventral hernia operation with fascial defect size from 3 to 6 cm will be recruited. Fifteen patients undergo rVHR and fifteen undergo hybrid operation.The main outcome measure is postoperative pain, evaluated with visual analogue scale (VAS: 0-10) preoperatively, at 1-week, at 1-month and at 1-year. Hernia recurrence will be evaluated with ultrasound examination at 1-year and QoL using the generic SF-36 short form questionnaire preoperatively, at 1-month and at 1-year.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ventral hernia size 3-6 cm
排除标准
- •previous ventral hernia
结局指标
主要结局
Robotic-assisted ventral hernia repair vs hybrid. Change in pain
时间窗: 1-year
VAS scale from 0 to 10. Zero in VAS is no pain and number ten is the highest possible pain
次要结局
- Robotic-assisted ventral hernia repair vs hybrid. Change in the social functioning status.(1-year)
研究者
Kakela Pirjo
clinical teacher, MD, PhD
Kuopio University Hospital