Percutaneous Internal Ring Suturing Versus Conventional Laparoscopic Repair of Congenital Inguinal Hernia: a Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- operative time
研究概览
简要总结
Background:comparison between percutaneous internal ring suturing vs Conventional Laparoscopic Repair of Congenital Inguinal Hernia in male patients. Methods : this is a prospective randomized study including 109 male patients with 120 CIHs Patients were randomly categorized into two groups. Group A were subjected to laparoscopic disconnection of the hernia sac and narrowing of the internal ring (IR). Group B underwent PIRS. The intended primary outcome was recurrence within 1 year, besides comparing the two techniques regarding operative time, efficacy, safety, cosmetic outcome, and postoperative complications.
详细描述
Introduction Since the 1990s laparoscopy has gained popularity in the management of Congenital inguinal hernia (CIH). Several laparoscopic techniques have been described, including laparoscopic disconnection of the hernial sac with narrowing of the internal ring (IIR) which was described to mimic the open technique, and the extraperitoneal approach involves using various types of needles under laparoscopic guidance to percutaneously secure a suture circumferentially around the internal ring, thus obliterating the sac opening. This study compared the short-term outcome of percutaneous internal ring suturing (PIRS) versus laparoscopic disconnection of the hernial sac with narrowing of the internal ring in children.
Materials and Methods
This study included 109 male patients with 120 CIHs during the period from May 2022 to May 2024. Patients were randomly categorized into two groups. Group A were subjected to laparoscopic disconnection of the hernia sac and narrowing of the internal ring (IR). Group B underwent PIRS. The intended primary outcome was recurrence within 1 year, besides comparing the two techniques regarding operative time, efficacy, safety, cosmetic outcome, and postoperative complications.
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
- None
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •male patients
- •age of 6 month to 5years
- •reduciable congenital inguinal hernia either unilateral or bilateral.
排除标准
- •incarcerated CIH
- •recurrent CIH
- •patients with undescended testis,
- •patients with hydrocele,
- •patients with chronic comorbidity such as congenital heart disease and severe chest troubles
研究组 & 干预措施
Group A
laparoscopic disconnection of the hernia sac and narrowing of the internal ring
干预措施: laparoscopic disconnection of the hernia sac (Procedure)
Group B
Percautaneous internal ring suturing
干预措施: Percutaneous internal ring suturing (Procedure)
结局指标
主要结局
operative time
时间窗: the time estimated during the operation
time of the procedure estimated after trocars insertion and Inflation of the abdomen till deflation of the abdomen
intraoperative safety
时间窗: the time estimated during the operation
injury of the vas deffernce , spermatic vessels , bleeding
Recurrence of the inguinal hernia
时间窗: 1 year
postoperative swelling in the inguinal region with gurgling sensation
次要结局
- cosmesis(1 year)