Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia 3 Armed Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- Operative time
研究概览
简要总结
Currently, there is a controversy regarding the best approach for simultaneous repair of bilateral inguinal hernia. The aim of this study was to compare the outcome of laparoscopic versus open repair of bilateral inguinal hernia
详细描述
This prospective randomized study included 120 consecutive patients with bilateral primary inguinal hernia treated at Alexandria university hospital in the period between June 2014 and February 2017. Patients were randomized by sealed envelopes into 3 groups, each includes 40 patients. Group I treated by laparoscopic transabdominal preperitoneal repair using 2 separate meshes, Group II treated by open preperitoneal mesh repair, while Group III treated by bilateral Lichtenstein repair. The 3 groups were compared regarding: operative time, postoperative complications, pain, hospital stay, return to normal activity and work, chronic groin pain, patient's satisfaction and 3 years recurrence rate.
Statistical Analysis
Numerical data in both groups was expressed as mean
± standard deviation (SD) and compared using One-way analysis of variance while categorical data was expressed as percentages and compared using Chi-squared test. Logistic regression test was used to determine predictors of postoperative complications. Differences were considered significant at p <0.05.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primary bilateral inguinal hernias in patients aged from 20 to 60 years
排除标准
- •Immune compromised patients,
- •Morbid obesity (BMI > 35 kg/m2)
- •Chronic liver or renal disease
- •Coagulopathy
- •High-risk patients unfit for major surgery (ASA III or IV)
- •Recurrent hernias
- •Complicated hernias
- •Massive scrotal hernias
- •Previous infra-umbilical surgery
- •Persistent groin pain due to other causes
结局指标
主要结局
Operative time
时间窗: Same day of surgery
Operative time (in minutes)
Early postoperative complications
时间窗: 30 days after the surgery
Any complications related to surgery developed within 30 days after the surgery
Postoperative pain 7 days after surgery
时间窗: 7 days after surgery
Pain intensity was assessed using the pain visual analogue scale (VAS) with values ranging from 1 (no pain) to 10 (worst possible pain)
次要结局
- Chronic postoperative pain(3 months after surgery)
- Hernia recurrence(3 years after surgery)
研究者
Mohamed El Messiry
Ass. Professor of Surgery
University of Alexandria