Comparison of Laparoscopic TransabdominalRetromuscular (TARM) Repair with extended view Totally Extraperitoneal – Rives Stoppa (eTEP-RS) Repair for Ventral Hernias - a Randomized Controlled Study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Operative time defined from first incision to last stitch between TARM versus e-TEP RS, recorded in minutes.
研究概览
简要总结
Purpose of the protocol - to compare the key differences between two types of Laparoscopic Hernia repair i.e. Transabdominal Retromuscular Repair (TARM) and Extended view Totally Extraperitoneal Rives Stoppa (eTEP-RS) Repair, primarily comparing operative time between the two approaches. The secondary outcomes being considered are - post-operative pain as VAS score at 24hr, 72hr and 7 days post-operatively, duration of hospital stay (in days) and days until return to work/daily routine. The study is being conducted to establish the benefits and disadvantages of approaching the retrorectus plane transabdominally i.e. after breaching the peritoneum versus creating the plane while working extraperitoneally.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18-65 years with primary midline ventral hernia, presenting to surgery OPD of Lok Nayak Hospital planned for laparoscopic hernia repair.
排除标准
- •Patients with defect size >6 cm
- •Recurrent hernias
- •Obstructed or strangulated (complicated) hernia.
结局指标
主要结局
Operative time defined from first incision to last stitch between TARM versus e-TEP RS, recorded in minutes.
时间窗: operative time assessed immediately at the end of surgery when the last stitch is placed.
次要结局
- 1. Postoperative pain using VAS score at 24 hours, 72 hours & 7 days post-operatively.(2. Duration of hospital stay(Days))