Comparing absorbable tackers vs fibrin glue mesh fixation in reducing postoperative pain and neuralgia in patients undergoing Extended laparoscopic total extraperitoneal inguinal hernia Repair (eTEP) - A double blinded randomized control trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- JIPMER
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To assess efficacy in reducing postoperative pain and neuralgia between fibrin glue and absorbable tacker in extended laparoscopic inguinal hernia repair.
研究概览
简要总结
A double blinded randomised control trial comparing efficacy between absorbable tacker and fibrin glue in mesh fixation reducing postoperative pain and neuralgia in patients undergoing laparossopic eTEP.Fibrin glue has emerged as avery effective alternative to absorbable tacker for atraumatic mesh fixation with its efficacy, tolerability , and lack of adverse effect. one group in mesh fixation we will use 2-3 absorbable tacks fixing it to cooper’s ligament and abdominal wall .other group mesh will be secured with fibrin glue applied to transversalis fascia.All participants will receive standardized postoperative analgesia.
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 total extraperitoneal inguinal hernia repair.
排除标准
- •Complicated (strangulated, incarcerated, obstructed, etc.) inguinal hernia.
- •Hernia patients with disorders of hemostasias and coagulation
- •Chronic pain due to previously operated opposite side or due to any other medical problems
- •Patients undergoing concomitant surgeries along with mesh repair
- •Patients in whom surgery is converted from eTEP to TAPP or open mesh repair in view of intra-operative difficulty
- •Patients with recurrent hernias.
结局指标
主要结局
To assess efficacy in reducing postoperative pain and neuralgia between fibrin glue and absorbable tacker in extended laparoscopic inguinal hernia repair.
时间窗: pain is assessed at 6hr,12hr,24hr,1 week and one month after surgery
次要结局
- To compare the perioperative 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 return to work) between the two groups(recurrence rates & pain after 6 months & 1 yea, ssi)
研究者
DR ANKIT KUMAR PANI
Jawaharlal institute of postgraduate medical sciences and research institute