Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia; 3 Armed Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 主要终点
- Postoperative pain after 24 hours
研究概览
简要总结
The best approach for simultaneous repair of bilateral inguinal hernia is controversial. The aim of this study is to compare the outcomes after laparoscopic versus open mesh repair of bilateral primary inguinal hernia
详细描述
This prospective study included 180 patients with bilateral primary inguinal hernia; randomized by sealed envelopes into 3 groups; each includes 60 patients. Group I treated by laparoscopic trans-abdominal pre-peritoneal (TAPP) repair using 2 separate meshes, Group II treated by open pre-peritoneal (PP) single mesh repair, while Group III treated by bilateral Lichtenstein repair. The 3 groups were compared regarding: operative time, postoperative complications, postoperative pain, 3 years-recurrence rate and patient's satisfaction.
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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
- Double (Participant, Investigator)
盲法说明
Sealed opaque envelopes containing computer generated random numbers
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with painless uncomplicated primary bilateral inguinal hernias
排除标准
- •Immune compromised patients
- •Coagulopathy
- •Chronic liver or renal disease
- •High-risk patients unfit for major surgery (ASA III or IV),
- •Massive scrotal hernias, Recurrent or Complicated hernias
- •Groin pain due to any other pathology
- •Previous infra-umbilical surgery
研究组 & 干预措施
Laparoscopic Trans-Abdominal Pre-Peritoneal (Lap TAPP group))
Both hernias were treated by laparoscopic trans-abdominal pre-peritoneal repair using 2 separate meshes fixed by endoscopic tackers
干预措施: Laparoscopic Trans-Abdominal Pre-Peritoneal (Procedure)
Open Pre-Peritoneal Repair ( Open PP group)
Both hernias were treated by open pre-peritoneal single mesh repair with suture fixation
干预措施: Open pre-peritoneal repair (Procedure)
Bilateral Lichtenstein repair (LICHT group)
treated by bilateral standard Lichtenstein repair using 2 separate meshes with suture fixation
干预措施: Bilateral Lichtenstein repair (Procedure)
结局指标
主要结局
Postoperative pain after 24 hours
时间窗: 24 hours after surgery
Pain intensity was assessed 24 hours after surgery using the pain visual analogue scale (VAS) with values ranging from 1 (no pain) to 10 (worst possible pain)
Operative time
时间窗: From skin incision until incision closure at the end of surgery
Operative time (in minutes)
Postoperative pain after 7 days
时间窗: 7 days after surgery
Pain intensity was assessed 7 days after surgery using the pain visual analogue scale (VAS) with values ranging from 1 (no pain) to 10 (worst possible pain)
Early postoperative complications
时间窗: Within 30 days after the surgery
All complication related to surgery developed within 30 days after the surgery
次要结局
- 3 years hernia recurrence rate(within 3 years after surgery)
- Patient's satisfaction score(within 3 years after surgery)
- Chronic Groin pain(After 3 months postoperatively)
研究者
Mohamed El Messiry
Assistant professor of Surgery
Alexandria University