A prospective, randomised controlled study to compare Intraperitoneal Onlay Mesh plus repair versus Transabdominal Pre peritoneal Mesh plus repair for patients with primary ventral hernia
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- To compare the average pain scores (VAS) between the two groups during first 24 hours post-operatively (average of pain scores at 6 hours, 12 hours and 24 hours)
研究概览
简要总结
Various methods have been designed to treat the ventral abdominal hernias. Initially, open surgeries were mainly performed. However, over the last few decades, laparoscopic treatment of ventral hernias have gained much popularity. Two important laparoscopic methods of ventral abdominal hernia repair- Intraperitoneal onlay mesh plus repair and transabdominal pre peritoneal mesh plus repair are being widely used. Through this RCT, we will be focusing on comparing these two surgical procedures in terms of postoperative pain and other postoperative complications like seroma formation, hernia recurrence, mesh infection and operative time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with small to medium sized hernias
- •Patients who are fit for general anaesthesia and laparoscopy
- •Providing consent and willing to follow up for 6 months.
排除标准
- •Patient refusal
- •Age less than 18 years
- •Patients undergoing emergency surgery
- •Complex and/or large sized hernias
- •Parastomal or recurrent hernias
- •Patients unfit for general anaesthesia 7.
结局指标
主要结局
To compare the average pain scores (VAS) between the two groups during first 24 hours post-operatively (average of pain scores at 6 hours, 12 hours and 24 hours)
时间窗: 6 hours, 12 hours, 24 hours after surgery
次要结局
- 1. Pain scores (VAS) at 6 hours, 12 hours, 48 hours, 2 weeks, 1 month, 3 months and 6 months post operatively(2. To compare the length of hospital stay and operative duration)
研究者
Varnik Goel
AIIMS NEW DELHI