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Inflammatory Stress Response in Pediatric Inguinal Hernia Repair

U

University Hospital of Split

Status

Completed

Conditions

C Reactive Protein
Surgery
Tumor Necrosis Factor Alpha
Inflammatory Response
White Blood Cell Count, Leukocytes
Children, Only
Inguinal Hernia, Indirect
Interleukin-6

Treatments

Procedure: Operation - PIRS
Procedure: Operation - MARCY

Study type

Interventional

Funder types

Other

Identifiers

NCT03203343
University hospital of Split

Details and patient eligibility

About

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.

Full description

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.

Enrollment

32 patients

Sex

Male

Ages

3 to 7 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

32 participants in 2 patient groups

PIRS group
Active Comparator group
Description:
Patients operated laparoscopically - PIRS technique
Treatment:
Procedure: Operation - PIRS
Marcy group
Active Comparator group
Description:
Patients operated by open modified Marcy technique
Treatment:
Procedure: Operation - MARCY

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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