Inguinal Hernioplasty: Comparative Study Between Laparoscopic Dual Approach, Laparoscopic Trans Abdominal Preperitoneal and Lichtenstein Procedures. A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- operative time
研究概览
简要总结
This study designed to compare the new laparoscopic dual approach to inguinal hernia repair with trans-abdominal preperitoneal (TAPP) and lichtenstein repair (open procedure)
详细描述
inguinal hernioplasty is a procedures where synthetic mesh is used to strengthen the inguinal tissues sites for hernia repair different methods used which is either anterior approach (open Lichtenstein) or laparoscopic posterior approach through the abdomen (TAPP) comparing these two methods by new approach which is considered to some extent a modified TAPP by pneumo-dissection of pre-peritoneal space with abdominal approach by lap. repair
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, Outcomes Assessor)
盲法说明
this is a randomized trial where the participants are selected randomly to each of the previous three groups , and the post operative assessment of complication and pain done by different surgical residents whom are not informed about the groups of study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male patient (older than 18y).
- •Not complicated.
- •No previous lower abdominal incisions (lower abdominal midline and lower paramedian incision in the same side of hernia).
- •No contraindication for general anesthesia.
- •Not recurrent.
排除标准
- •any one not in fulfill inclusion criteria
研究组 & 干预措施
group A (dual approach lap hernioplasty)
dual approach laparoscopic inguinal hernioplasty by combination of TAPP (group B) and pneumo-dissection preperitoneal instead of sharp dissection
干预措施: dual approach laparoscopic inguinal hernioplasty (Procedure)
group C (Lichtenstein hernioplasty)
open inguinal hernioplasty (lichtenstein) repair through inguinal incision and dissection of the sac anteriorly , excision of the sac and then mesh fixation in the posterior wall of inguinal canal
干预措施: (lichtenstein) repair (Procedure)
group B (TAPP)
trans-abdominal preperitoneal hernioplasty (TAPP) after induction of pneumoperitoneum through peritoneal approach peritoneal incision and preperitoneal dissection then mesh fixation done
干预措施: TAPP (Procedure)
结局指标
主要结局
operative time
时间窗: from the inflation of the abdomen till deflation and port closure ---for lichtenstein from skin incision to skin closure.
operative time will be measured in minutes for each procedure.and comparing three groups ( dual approach , TAPP and Lichtenstein ) in operative time which determined as follow: * from the inflation of the abdomen till deflation and port closure * for Lichtenstein from skin incision to skin closure
次要结局
- intraoperative injuries(intra operative)
- recurrence(3 months, 6 months and one year)
- post operative pain(immediately post operative and 6 ,12, 24 hours and two weeks post operative)
- intra operative bleeding(intraoperative)
- post operative wound complication(2 weeks post operative ,3 ,6 and 12 months postoperative)
- post operative chronic pain(follow up at 3 months , 6 months and one year for pain assessment by VAS)
研究者
Sulaiman Abdulqader Saif Alshameri
general surgeon
Assiut University