跳至主要内容
临床试验/NCT05702710
NCT05702710已完成不适用

Percutaneous Internal Ring Suturing is a Safe and Effective Method in the Minimal Invasive Treatment of Inguinal Hernia in Neonates

Maltepe University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2023年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Surgery Time

研究概览

简要总结

In this study, preoperative physical examination findings, peroperative findings and data, and postoperative follow-up results of newborns who underwent inguinal hernia repair with PIRS ("Percutaneous Internal Ring Suturing") method will be evaluated retrospectively.

详细描述

Congenital inguinal hernia is one of the most common surgical pathologies of childhood. Its treatment includes high ligation of the patent processus vaginalis by open or laparoscopic method. There are many described minimally invasive/laparoscopic repair techniques of inguinal hernias in children. One of them is "percutaneous internal ring suturing" or "Percutaneous Inner Ring Suturing".

There are many studies on the PIRS method in children. Two of these studies are prospective clinical studies published previously by the investigators of this study: in the first, the PIRS method was shown to be a safe and effective method for minimally invasive repair of inguinal hernia in children, and in the second, the use of subparalytic laryngeal masks in anesthesia of patients who underwent PIRS was shown to be sufficient for airway protection and anesthesia management in children undergoing laparoscopy.

Although there are many studies on the repair of inguinal hernia in children with PIRS or other minimally invasive methods in the last decade, there are very limited studies on the use of these methods in newborns, a special group of childhood patients. In the literature, there is no study examining only newborn patients. In this context, the study will be a first in the literature.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Having undergone PIRS surgery at the study institute between October 1, 2015 and January 1, 2023
  • Age between 0-28 days

排除标准

  • Age > 28 days
  • Having had surgery with open surgery
  • Having another surgical procedure performed in the same session

结局指标

主要结局

Surgery Time

时间窗: Measured as time from skin prep until dressing is performed (approx. 20-30minutes)

Time from skin prep to end of dressing

Presence of Contralateral Patent Processus Vaginalis

时间窗: Measured during surgery (approx. 5-10minutes)

Whether a patent processus vaginalis was observed and repaired on laparoscopy

Anesthesia Time

时间窗: Measured in minutes from induction to awakening (approx. 30-40minutes)

Time from induction to awakening

次要结局

  • Type of Airway Management Used(Measured throughout surgery (20-30minutes))
  • Dose of Muscle Relaxant(Measured throughout surgery (20-30minutes))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Assoc. Prof. David T. Thomas, M.D.

Associate Professor

Maltepe University

研究点 (1)

Loading locations...

相似试验

Minimal Invasive Treatment of Inguinal Hernia in... | 临床试验