Exploring Efficacy and Safety: A Comparative Prospective Cohort Study Of Needlescopic Inguinal Hernia Repair Versus Open Herniotomy In Pediatrics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Intraoperative outcomes
研究概览
简要总结
This study aims to compare between two techniques to treat hernia in children which are Needlescopic inguinal hernia repair and Open classic surgery as regard operative time, cosmetic appearance, recurrence and other complications
详细描述
Study Procedures:
Preoperative assessment :
- Detailed history including age, sex, complain (groin swelling increasing in size with cough and crying) and past surgical and medical history.
- General and local examination including reducible swelling forwards, upwards and laterally (inguinoscrotal in males and inguinal in females). If any sign or symptoms of irreducibility or strangulation present (abdominal distention, vomiting, constipation, tense, tender or erythematous inguinal swelling) patient should be excluded.
- Investigations: Inguinal ultrasound is only done in cases of query history or uncertain examination or to exclude bilateral pathology.
- Preoperative preparation included complete blood count, coagulation profile and complete fasting hours.
Operative technique:
Anaesthesia: General anaesthesia using endotracheal intubation and muscle relaxant plus local anaesthesia in the form of caudal block.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients.
- •Age between 4 to 12 years.
- •Bilateral or unilateral indirect inguinal hernia
排除标准
- •Age below 4 year and above 12 years.
- •Irreducible inguinal hernia.
- •Recurrent inguinal hernia.
- •Patient not fit for Laparoscopic Surgery.
- •Direct inguinal hernia.
- •Sliding type of indirect inguinal hernia.
- •Double pathology like associated undescended testis, vaginal hydrocele, encysted hydrocele and hydrocele of canal of Nuck.
研究组 & 干预措施
Open herniotomy Group
干预措施: Open herniotomy (Procedure)
Needlescopic percutaneous Internal Ring Suturing group
干预措施: Needlescopic percutaneous Internal ring suturing (Procedure)
结局指标
主要结局
Intraoperative outcomes
时间窗: From the start of anesthesia till the end of operation
Operative time. / Intraoperative complication. / Rate of conversion to open surgery.
1st Post-operative visit
时间窗: After 1 week post operative
for removal of wound dressing and assessment of wound for infection if present or recurrence.
2nd post-operative visit
时间窗: After 1 month post operative
For assessment of : Cosmetic appearance. Recurrence. Hydrocele if present
3rd post-operative visit
时间窗: After 3 month post operative
tfor assessment of : Cosmetic appearance. Recurrence. Hydrocele
次要结局
未报告次要终点