CTRI/2025/04/085911招募中2/3 期
Comparing sutures with tackers (ST) versus tackers alone [Double crown technique (DC)] for mesh fixation in reducing post-operative pain in patients undergoing laparoscopic ventral hernia repair (LVHR)- A double blinded randomized control trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- JIPMER
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- to compare postoperative pain scores between sutures with tackers vs tackers alone in laparoscopic hernia surgery
研究概览
简要总结
ouble-crown fixation of intra-peritoneal mesh during laparoscopic ventral hernia repair was quicker, was less painful immediately post-operative and after 3 months, and did not increase the recurrence rate at 24 months. In hernias at a distance from the bony borders of the abdomen, transfascial sutures can be omitted if a double crown of tackers is placed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •All consenting patients planned for elective laparoscopic hernia repair.
排除标准
- •1.All hernias close to bony structures
- •Hernia patients with bleeding
- •Chronic pain due problems
- •Patients undergoing concomitant surgeries along with mesh repair
- •Parastomal hernias
- •Large hernias that require skin excision/ revision.
结局指标
主要结局
to compare postoperative pain scores between sutures with tackers vs tackers alone in laparoscopic hernia surgery
时间窗: pain is assessed at 6hours, 12 hours, 24hours, 1 week and one month after surgery
次要结局
- reduction in recurrence rates, seroma, hematoma formation, length of hospital stay(recurrence rates & pain after 6 months & 1 yea, ssi within 90 days, seroma formation within 1 month)
研究者
Karavadi Anuradha
Jawaharlal institute of postgraduate medical sciences and research institute
研究点 (1)
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