Comparison of Extended Totally Extra Peritoneal Repair (ETEP) and Subcutaneous Onlay Endoscopic Approach (SCOLA) for the Treatment of Para Umbilical Hernias (PUH) in Terms of Intraoperative Factors(Operative Time, Hernial Contents, Divarication of Recti, Conversion to Any Other Technique) and Postoperative Complications( Surgical Site Infection, Seroma Formation, Postoperative Pain, Rescue Analgesia, Drain Output)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Hernial contents
研究概览
简要总结
The goal of this clinical trial is to learn if one of two surgical techniques works better for treating paraumbilical hernias in adult men and women between 18 and 65 years old.
The main questions it aims to answer are:
Does one technique lead to fewer complications after surgery, such as infection or fluid buildup (seroma)?
Does one technique result in less pain or a shorter operating time?
Researchers will compare the ETEP repair group to the SCOLA repair group to see if one method leads to better outcomes for patients.
Participants will:
Be randomly assigned to receive either the ETEP or SCOLA surgical repair.
Have their surgery and recovery tracked by the research team.
Attend follow-up visits for up to six months to check for any complications.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults of the age group from 18 to 65 years
- •Patients of both genders admittes with the diagnosis of para-umbilical Hernias through the outdoor department, documented on clinical examination by a consultant general surgeon.
排除标准
- •Patients with a hernial defect more than 5cm, documented in the perioperative findings
- •Patients with complicated hernias, including irreducible and obstructed varieties, documented on clinical findings.
- •Patients who require abdominoplasty, opinion given by the operative surgeon.
- •Patients with intermediate to high risk of MACE during the surgery, documented on the fitness form filled by the cardiology team.
- •Patients with previous midline incision or laparotomy, documented on clinical examination.
研究组 & 干预措施
Extended Totally Extra Peritoneal Repair
干预措施: Extended Totally Extra Peritoneal Repair (Procedure)
Subcutaneous OnLay endoscopic Approach
干预措施: Subcutaneous On-Lay Endoscopic Approach (Procedure)
结局指标
主要结局
Hernial contents
时间窗: 4 hours
Hernial contents will include fat, omentum or bowel.
Divarication of recti
时间窗: 4 hours
Divarication of recti An inter recti distance more than 2cm will be considered as diastasis of recti.
Postoperative pain
时间窗: 6 month
Postoperative pain Postoperative pain will be assessed by the visual analogue score( 0-10) with zero showing no pain and 10 showing maximum pain.
Rescue analgesia
时间窗: 1 month
Rescue analgesia Rescue analgesia will include injection nalbuphine 3mg given for breakthrough pain. VAS score more than 4 will be considered as breakthrough pain. It will be measured as rescue analgesia given or not.
Drain out put
时间窗: 1 month
Drain output Drain output will include amount and type of fluid (blood, serous, serosanginous,). Drains will be removed when drain out will be less than 25ml over 24h. Drain output more than 100ml will be considered as high drain output and less than 100ml will be considered as low output. Drain out put will be measured as high output or low output.
Operative Time
时间窗: 4 hours
Operative time will include time from the first incision to approximation of skin by skin stapler.
Conversion to Any Other Procedure
时间窗: 4 hours
If the operating surgeon has to shift the operative technique to IPOM or open hernia repair then this will be considered as conversion to any other procedure.
Seroma Formation
时间窗: 6 months
Collection of serous fluid at the operative site after hernia repair surgery within 30 days once the drains placed at the site of surgery would been out.
Surgical Site Infection
时间窗: 1 month
If a Patient presents with hyperemia and pus discharge from wound within 30 days of operation requiring opening of wound or change in antibiotics will be labeled as surgical site infection.
次要结局
未报告次要终点