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Completed

NCT Number: NCT03203343

Inflammatory Stress Response in Pediatric Inguinal Hernia Repair

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.

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Key information

Age range

3 year–7 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University hospital of Split

Split, Split-Dalmatia County, 21000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Operation - PIRS

Procedure

Operation by its known design for PIRS group

Operation - MARCY

Procedure

Operation by its known design for MARCY group

Primary outcomes

  1. Change in inflammatory stress response (IL6)

    Time frame: 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

  2. Change in inflammatory stress response (CRP)

    Time frame: 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

  3. Change in inflammatory stress response (TNF alpha)

    Time frame: 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

  4. Change in inflammatory stress response (Leukocytes WBC)

    Time frame: 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

Secondary outcomes

  1. Subjective pain assessment

    Time frame: 24 hours after and 6 days after surgery

    Visual analog pain scale

  2. Subjective pain assessment

    Time frame: 6 days after surgery

    Visual analog pain scale

Sponsors and collaborators

Lead sponsor

University Hospital of Split

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 29, 2017
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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