CTRI/2022/04/042048尚未招募不适用
Comparison between Sutures, N-butyl-2cyanoacrylate and Self- gripping mesh in Lichtenstein Hernia repair- A multi arm randomized control trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- JIPMER
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- To assess the efficacy of sutures vs N-butyl-2-cy- anoacrylate vs self-gripping mesh for mesh fixation in reducing postoperative pain during elective primary unilateral inguinal hernia repair
研究概览
简要总结
This study is going to be a three arm RCT comparing three efficient methods of mesh fixation in elective hernia repair to compare the outcomes of surgery post operatively. Using sutures, N-butyl-2cyanoacrylate and self gripping mesh we aim to compare the three in different aspects of probable improvement in the age old technique of Meshplasty with sutures which is widely used and is known to be commonly associated with post operative chronic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •All consenting patients with primary elective uni- lateral uncomplicated inguinal hernia planned for open mesh repair.
排除标准
- •1.Recurrent or giant inguinal hernia with loss of do- main.
- •2.Hernia patients with disorders of hemostasis and coagulation 3.Chronic pain due to previously operated opposite side or due to any other medical problems 4.Patients undergoing concomitant surgeries along with mesh repair.
结局指标
主要结局
To assess the efficacy of sutures vs N-butyl-2-cy- anoacrylate vs self-gripping mesh for mesh fixation in reducing postoperative pain during elective primary unilateral inguinal hernia repair
时间窗: day 0,1,2,7,30 of surgery
次要结局
- 1.To compare the short-term outcomes (local numbness and hematoma, seroma, rate of SSI, urinary retention, length of operation, intraoperative time for mesh fixation, Length of hospital stay and time to re- turn to work) between the three groups(2.To compare the long-term outcomes (Chronic pain, recurrence and cost benefit analysis), between the three groups.)
研究者
研究点 (1)
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