Sublay vs. Onlay mesh hernioplasty in ventral hernia - A double blinded randomised 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
- 87
- 试验地点
- 1
- 主要终点
- To compare the incidence of seroma formation, wound infection between the sub-lay and on-lay mesh repair.
研究概览
简要总结
Ventral hernia repair is among the most frequently performed surgical operation globally and the two operative techniques most frequently used in cases of ventral hernia are the onlay and sublay repair.
The repair of ventral hernias has always been a big challenge to the surgeons.
Different mesh placement techniques has been followed. Onlay (Overlay) repair places the mesh directly on the anterior fascia. Inlay repair places the mesh inline with the hernia defect and secures the mesh circumferentially to the edges of the fascia. Sublay repair refers to retro rectus or preperitoneal mesh placement. Intraperitoneal onlay mesh (IPOM) refers to an intraperitoneal mesh position.
Mesh hernioplasty method was considered as a golden choice to prevent or minimize incidence of recurrence but the question is where surgeons should put the mesh sublay or onlay? Although, it remains uncertain as to which repair technique has shown to be more successful.
This study aims to compare Onlay with Sublay mesh repair for open incisional hernia and evaluate outcomes related to post-operative complications, recurrence of hernia, length of hospital stay etc.
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 99.00 Year(s)（—）
- 性别
- All
入选标准
- •ALL ELECTIVE PATIENTS ABOVE 18 YEARS WHOA RE TO UNDERGO ELECTIVE MESHPLASTY FOR VENTRAL HERNIA REPAIR.
- •2.) VENTRAL HERNIA WITH SIZE DEFECT BETWEEN 2-8CM.
排除标准
- •MORBID OBESITY WITH BMI > 40KG/M2 PATIENTS WITH ABDOMINAL DISEASE AND END STAGE LIVER DISEASE PATIENTS WITH OBSTRUCTIVE UROPATHY.
- •BPH PATIENTS PRESENTING AS AN EMERGENCY LIKE STRANGULATED HERNIA WITH SIGNS OF OBSTRUCTION PRE EXISTING SIGNS OF INFECTION AT THE SITE OF HERNIA.
结局指标
主要结局
To compare the incidence of seroma formation, wound infection between the sub-lay and on-lay mesh repair.
时间窗: Daily during hospital stay after the procedure and then telephonic follow up on 7-10 days, 1 month and 3 month from procedure date
次要结局
- To assess the impact of these two surgical techniques on the basis of operative time, postoperative pain (POD 0, 1 and 2), recurrence on drain output, length of hospital stay etc.