Needlescopic Versus Traditional Laparoscopic Inguinal Hernia Repair in Pediatrics (A Prospective Comparative Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Operative time
研究概览
简要总结
The aim of the study is to evaluate the results of Needlescopic inguinal hernia repair in comparison with traditional laparoscopic repair in children as regard operative time, cosmetic appearance, recurrence and other complications.
详细描述
Patients and methods:
- Place of the study: The study will be held in Department of Pediatric surgery in Sohag University Hospital.
- Type of the study: Prospective comparative Cohort study.
- Duration of the study: The study will last for 6 to 9 months starting from the date of acceptance of the protocol.
- Ethical considerations: The study will be carried out after approval by scientific and ethical committees of Sohag faculty of medicine.
- Method of the study:
Preoperative assessment:
- Demographic data: e.g. name, age, sex .... etc.
- History: e.g. complaint, present history and past surgical and medical history...etc.
- General and local examination: e.g. laterality, associated anomalies .... etc.
- Investigations:
Routine labs. Imaging: to confirm diagnosis in the affected side, to evaluate contralateral side, bilateral testicular volume as volumetric stander to evaluate testicular atrophy postoperative and other anomalies.
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
- Single (Participant)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Include patients presented with inguinal hernia with age < 18 years.
排除标准
- •Age above 18 years.
- •Complicated inguinal hernia (e.g. irreducibility, obstruction and strangulation).
- •Pervious lower abdominal surgeries.
结局指标
主要结局
Operative time
时间窗: during operation
Operative time from start of incision making till end of operation and closure of incisions
Intraoperative complications
时间窗: during operation
as injury to inferior epigastric vessels, vas deferens and major pelvic vessels
Rate of conversion to open surgery.
时间窗: during operation
rate of conversion from laparoscopic surgery to open surgery.
次要结局
- Cosmetic appearance(1 and 3 months after the surgery)
- Recurrence(1 and 3 months after the surgery)
- Hydrocele(1 and 3 months after the surgery)
- Testicular atrophy(1 and 3 months after the surgery)
研究者
Abdelaziz Ali Abdelaziz
M.B.B.Ch., Resident in Pediatric Surgery Department Sohag University Hospitals
Sohag University