Comparative Study Between Etep-rs and Ipom Plus for Abdominal Wall Hernias
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- Hernia Recurrence Rate
研究概览
简要总结
This study aims to compare the outcomes of Enhanced View Totally Extraperitoneal Rives-Stoppa (eTEP-RS) repair and Intraperitoneal Onlay Mesh Plus (IPOM Plus) repair in the management of ventral wall hernias. The comparison includes operative time, post-operative pain, hospital stay, surgical site occurrences, and recurrence rates. Patients will be prospectively enrolled and allocated into two groups based on the surgeon's discretion or patient-specific criteria.
详细描述
Abdominal wall hernias are common surgical conditions, and multiple techniques have evolved for their repair. eTEP-RS is a relatively newer, minimally invasive approach that combines the principles of the Rives-Stoppa retromuscular mesh placement with the benefits of laparoscopic surgery. IPOM Plus, on the other hand, is a widely practiced technique involving intraperitoneal mesh placement with defect closure.
This prospective comparative study is designed to evaluate the effectiveness and safety of eTEP-RS versus IPOM Plus in patients undergoing elective repair of ventral or incisional hernias. The study will assess intra-operative parameters (e.g., duration of surgery, blood loss), early post-operative outcomes (pain score, duration of hospital stay), surgical site complications (seroma, infection, mesh-related issues), and long-term outcomes (recurrence, quality of life).
Patients fulfilling inclusion criteria will be assigned to one of the two arms. Standardized protocols will be followed for pre-operative work-up, anesthesia, surgical steps, and post-operative care. Data will be analyzed to determine if one technique offers superior clinical outcomes, better patient satisfaction, or reduced recurrence
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient with uncomplicated ventral hernia with defect size between 2 cm and 5 cm
- •Age between 18 years and 60 years.
- •elective surgical cases(non emergency)
排除标准
- •defect size greater than 5 cm.
- •patient not giving consent.
- •patient with lateral HERNIAS.
- •patient with complicated ventral HERNIAS like irreducible , obstructed and strangulated HERNIAS.
- •pregnant and lactating women.
- •patient on anticoagulants.
- •recurrent hernia.
- •patient not fit for GA.
- •POOR GENERAL CONDITION.
结局指标
主要结局
Hernia Recurrence Rate
时间窗: Up to 6 months post-surgery
Clinical or radiological evidence of hernia recurrence during follow-up.
Postoperative Pain Score
时间窗: 6 months
Postoperative pain will be assessed using the Visual Analogue Scale (VAS) 24 hours, and 7 days, 30 days and 6 months after surgery. Pain intensity will be assessed using the Visual Analog Scale (VAS). The scale ranges from 0 to 10, where: 0 = No pain 10 = Worst imaginable pain Higher scores indicate a worse outcome.
次要结局
- Operative Time(Intraoperative)
- Duration of Postoperative Hospital Stay(DAY 1 TO DAY 15)
- Incidence of Surgical Site Occurrences (SSOs)(Within 30 days post-surgery)
- Time to Return to Normal Activities(Within 30 days postoperatively)
- Incidence of Surgical Site Occurrences (SSOs)(Within 30 days post-surgery)
- Time to Return to Normal Activities(Within 30 days postoperatively)
研究者
Kavita Sijwali
Junior resident, DEPARTMENT OF GENERAL SURGERY
GSVM Medical College