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Inflammatory Stress Response in Pediatric Inguinal Hernia Repair

NCT03203343 — Not applicable, Completed, 32 participants, University Hospital of Split

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

RegistryNCT03203343
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment32 (Actual)
SponsorUniversity Hospital of Split (Other)
ConditionsInguinal Hernia, Indirect, Children, Only, Inflammatory Response, Surgery, Interleukin-6, Tumor Necrosis Factor Alpha, C Reactive Protein, White Blood Cell Count, Leukocytes
InterventionsOperation - PIRS, Operation - MARCY (Procedure)
Datesstart 2017-05-01, primary completion 2018-06-01, completion 2018-06-25, first posted 2017-06-29, last updated 2018-12-19
Locations1 site in Croatia

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All trials for Inguinal Hernia, Indirect All trials for Children, Only All trials of Operation - PIRS All trials of Operation - MARCY

-Summary

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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+Detailed 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.

+Arms and interventions

ArmTypeInterventionsDescription
PIRS groupActive comparatorProcedure: Operation - PIRSPatients operated laparoscopically - PIRS technique
Marcy groupActive comparatorProcedure: Operation - MARCYPatients operated by open modified Marcy technique
  • Operation - PIRS (Procedure): Operation by its known design for PIRS group
  • Operation - MARCY (Procedure): Operation by its known design for MARCY group

+Outcome measures

Primary outcomes

  • Change in inflammatory stress response (IL6) [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) [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 (TNF alpha) [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 (Leukocytes WBC) [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

  • Subjective pain assessment [24 hours after and 6 days after surgery]: Visual analog pain scale
  • Subjective pain assessment [6 days after surgery]: Visual analog pain scale

+Eligibility

Sex: Male, ages: 3 Years to 7 Years, 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

+Locations (1)

FacilityCityCountryStatus
University hospital of SplitSplit, Split-Dalmatia CountyCroatia

+Publications

  • Results publication: Jukic M, Pogorelic Z, Supe-Domic D, Jeroncic A. Comparison of inflammatory stress response between laparoscopic and open approach for pediatric inguinal hernia repair in children. Surg Endosc. 2019 Oct;33(10):3243-3250. doi: 10.1007/s00464-018-06611-y. Epub 2018 Dec 3. PMID 30511312

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