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临床试验/NCT03203343
NCT03203343已完成不适用

Comparison of Inflammatory Stress Response Between Laparoscopic and Open Approach for Pediatric Inguinal Hernia Repair

University Hospital of Split2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2017年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
2
主要终点
Change in inflammatory stress response (TNF alpha)

研究概览

简要总结

Today there are various surgical techniques for inguinal hernia. In this study, investigators want to compare the ''PIRS'' operating technique laparoscopy and modified "Marcy" operating technique with open inguinal access. Investigators would compare both groups to find out witch one does the lesser inflammatory stress response on the organism.

详细描述

Inguinal hernia represents the protrusion of the abdominal cavity contents through the inguinal canal. Today there are various surgical techniques for inguinal hernia. In this study, investigators want to compare two standard methods that are regularly performed at the University hospital of Split at department of pediatric surgery. These are the ''PIRS'' operating technique laparoscopy and modified "Marcy" operating technique with open inguinal access. The choice of operating technique depends solely on the choice of a chosen pediatric surgeon. Given the fact that the child is indicated for an operation, regardless of participation in the study, there are no significant risks of participating in this study, except for possible but rare complications resulting from the peripheral venous blood draw (haematoma, soreness and pain). To carry out this study, the child should be taken (drawn) 3 peripheral venous blood samples (on day of operation, 24 hours after surgery and 6 days after surgery) from which the laboratory parameters are taken and counted (Leukocytes, C - Reactive Protein, Interleukin 6 and Tumor necrosis factor α).

Lab results would be compared between both groups to find out witch one does the lesser inflammatory stress response on the organism.

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
3 Years 至 7 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • male children with inguinal hernia at age of 3 to 7
  • one-sided inguinal hernia

排除标准

  • Female children
  • recurrent hernia
  • bilateral hernia
  • age less than 3 y, more than 7 y
  • any general inflammatory process, illness
  • intraoperative complications which may interfere with inflammatory stress response

研究组 & 干预措施

Marcy group

Active Comparator

Patients operated by open modified Marcy technique

干预措施: Operation - MARCY (Procedure)

PIRS group

Active Comparator

Patients operated laparoscopically - PIRS technique

干预措施: Operation - PIRS (Procedure)

结局指标

主要结局

Change in inflammatory stress response (TNF alpha)

时间窗: 3 measurements: preoperative, 24 hours after and 6 days after surgery

measurement of Tumor necrosis factor alpha in pg/mL (according to manufacturer), change of the value in three time frames like mentioned below

Change in inflammatory stress response (IL6)

时间窗: 3 measurements: preoperative, 24 hours after and 6 days after surgery

measurement of IL6 in pg/mL (according to manufacturer), change of the value in three time frames like mentioned below

Change in inflammatory stress response (CRP)

时间窗: 3 measurements: preoperative, 24 hours after and 6 days after surgery

measurement of C - reactive protein in mg/L, change of the value in three time frames like mentioned below

Change in inflammatory stress response (Leukocytes WBC)

时间窗: 3 measurements: preoperative, 24 hours after and 6 days after surgery

measurement of white blood cell count in 10\^9/L, change of the value in three time frames like mentioned below

次要结局

  • Subjective pain assessment(6 days after surgery)

研究者

发起方
University Hospital of Split
申办方类型
Other
责任方
Principal Investigator
主要研究者

Miro Jukić

M.D.

University Hospital of Split

研究点 (2)

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