Short Term Outcome of Laparoscopic Trans-abdominal Preperitoneal (TAPP) Inguinal Hernia Repair Without Mesh Fixation, Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- postoperative pain
研究概览
简要总结
comparison between two groups of participants suffering inguinal hernia each group 23 individual all underwent laparoscopic trans-abdominal inguinal hernia repair first group received mesh fixation the second underwent no fixation , results of follow up in the first year were compared together
详细描述
This comparative study was performed in Zagazig university hospitals, general surgery department in the time period between july 2018 and june 2020 0n 46 patients undergoing laparoscopic trans abdominal preperitoneal (TAPP) repair for un complicated unilateral inguinal hernia.
Patient selection; In this study we enrolled patients above
- 18 years old suffering unilateral,
- non -recurrent,
- un-complicated inguinal hernia. We excluded patients with
- previous abdominal or pelvic surgery,
- unfit with laparoscopic surgery,
- those with ascites,
- abdominal malignancy
- on chemotherapy and immune-compromised patients.
Randomization; using computer generated random numbers , the study participants were randomly allocated into two equal groups each group 23 individual, the first group; group A; patients underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was fixed in position using absorbable Vicryl tacks (abstack30 medtronic), and group B patient underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was placed in position without fixation.
All the study participants were subjected to thorough history taking, detailed clinical examination, determination of the presence of inguinal hernia, measurement of the hernia defect diameter by ultrasound or computerized tomography in difficult cases, preoperative laboratory tests were performed as per usual
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, Care Provider)
盲法说明
the participants and the follow up surgeon don't know which received fixation
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
- •18 years old suffering unilateral,
- •non -recurrent,
- •un-complicated inguinal hernia.
排除标准
- •previous abdominal or pelvic surgery,
- •unfit with laparoscopic surgery,
- •those with ascites,
- •abdominal malignancy
- •on chemotherapy and immune-compromised patients.
结局指标
主要结局
postoperative pain
时间窗: 6 month
pain in the first 6 month of surgery measured by visual analogue scale
hernia recurrence
时间窗: 1 year
recurrence of inguinal hernia measured by computed tomography of the abdomen
次要结局
未报告次要终点
研究者
Hazem Nour Abdellatif
Assistant professor
Zagazig University