Randomised control trial comparing eTEP (extended totally extraperitoneal repair) vs IPOM (intraperitoneal onlay mesh) for ventral hernia repair.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain score on Post-operative Day 1 measured using Visual Analogue Scale.
研究概览
简要总结
Title:
RANDOMISED CONTROL TRIAL COMPARING ETEP (EXTENDED TOTALLY EXTRAPERITONEAL REPAIR) VERSUS IPOM (INTRAPERITONEAL ONLAY MESH) FOR VENTRAL HERNIA REPAIR.
Introduction:
Ventral hernia repair still remains a significant challenge in surgery, with laparoscopic techniques having greatly evolved over time. IPOM and eTEP are two promising methods for hernia repair.
Aims:
To investigate the efficacy and safety of eTEP and IPOM approach in ventral hernia repair.
Objectives:
Primary objective is to compare immediate post-operative pain scores on POD1 (using VAS).
Secondary objectives is comparison of postoperative pain on Day 30 and 90, quality of life and other surgical site occurrences.
Methodology:
A single centre randomised control trial of duration one year will be conducted on 40 patients undergoing uncomplicated ventral hernia repair, having abdominal wall defect size within 2 to 7 cm, where 20 patients will be assigned to each IPOM and eTEP study groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patient above and including 18yrs of age.
- •Primary ventral or incisional hernia defect.
- •Hernia defect size greater than or equal to 2cm and lesser than or equal to 7cm.
- •Patient fit to tolerate General Anesthesia.
- •Patient eligible for repair via manual invasive procedure.
- •Should be able to give consent to participate in trial.
排除标准
- •Hernia defect size more than 7cm and less than 2cm
- •Hernia defect require open surgical approach.
- •Recurrent hernia after repair by recto-rectus mesh placement.
- •Patient not willing to give consent.
- •Patient not fit for general anesthesia.
结局指标
主要结局
Pain score on Post-operative Day 1 measured using Visual Analogue Scale.
时间窗: Day 1
次要结局
- Pain in post-operative period measured on follow-up at Day 30 & Day 90 using Visual Analogue Scale.(Day 30 & 90)
- Wound events such as surgical site infection (SSI) & surgical site occurrences requiring procedural intervention.(Till day 180)
- Abdominal wall-specific quality of life measured using Hernia-related quality of life survey(Day 180)
研究者
Saptarshi Mondal
Indira Gandhi Institute of Medical Sciences, Patna