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Inflammatory Stress Response in Pediatric Inguinal Hernia Repair

Primary Purpose

Inguinal Hernia, Indirect, Children, Only, Inflammatory Response

Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Operation - PIRS
Operation - MARCY
Sponsored by
University Hospital of Split
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia, Indirect focused on measuring Inguinal Hernia, Indirect, Children, Only, Inflammatory Response, Surgery, Interleukin-6, Tumor necrosis factor alpha, C reactive protein, Leukocytes

Eligibility Criteria

3 Years - 7 Years (Child)MaleAccepts 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

Sites / Locations

  • University hospital of Split

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PIRS group

Marcy group

Arm Description

Patients operated laparoscopically - PIRS technique

Patients operated by open modified Marcy technique

Outcomes

Primary Outcome Measures

Change in inflammatory stress response (IL6)
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)
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)
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)
measurement of white blood cell count in 10^9/L, change of the value in three time frames like mentioned below

Secondary Outcome Measures

Subjective pain assessment
Visual analog pain scale
Subjective pain assessment
Visual analog pain scale

Full Information

First Posted
June 16, 2017
Last Updated
December 17, 2018
Sponsor
University Hospital of Split
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1. Study Identification

Unique Protocol Identification Number
NCT03203343
Brief Title
Inflammatory Stress Response in Pediatric Inguinal Hernia Repair
Official Title
Comparison of Inflammatory Stress Response Between Laparoscopic and Open Approach for Pediatric Inguinal Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Split

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia, Indirect, Children, Only, Inflammatory Response, Surgery, Interleukin-6, Tumor Necrosis Factor Alpha, C Reactive Protein, White Blood Cell Count, Leukocytes
Keywords
Inguinal Hernia, Indirect, Children, Only, Inflammatory Response, Surgery, Interleukin-6, Tumor necrosis factor alpha, C reactive protein, Leukocytes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PIRS group
Arm Type
Active Comparator
Arm Description
Patients operated laparoscopically - PIRS technique
Arm Title
Marcy group
Arm Type
Active Comparator
Arm Description
Patients operated by open modified Marcy technique
Intervention Type
Procedure
Intervention Name(s)
Operation - PIRS
Intervention Description
Operation by its known design for PIRS group
Intervention Type
Procedure
Intervention Name(s)
Operation - MARCY
Intervention Description
Operation by its known design for MARCY group
Primary Outcome Measure Information:
Title
Change in inflammatory stress response (IL6)
Description
measurement of IL6 in pg/mL (according to manufacturer), change of the value in three time frames like mentioned below
Time Frame
3 measurements: preoperative, 24 hours after and 6 days after surgery
Title
Change in inflammatory stress response (CRP)
Description
measurement of C - reactive protein in mg/L, change of the value in three time frames like mentioned below
Time Frame
3 measurements: preoperative, 24 hours after and 6 days after surgery
Title
Change in inflammatory stress response (TNF alpha)
Description
measurement of Tumor necrosis factor alpha in pg/mL (according to manufacturer), change of the value in three time frames like mentioned below
Time Frame
3 measurements: preoperative, 24 hours after and 6 days after surgery
Title
Change in inflammatory stress response (Leukocytes WBC)
Description
measurement of white blood cell count in 10^9/L, change of the value in three time frames like mentioned below
Time Frame
3 measurements: preoperative, 24 hours after and 6 days after surgery
Secondary Outcome Measure Information:
Title
Subjective pain assessment
Description
Visual analog pain scale
Time Frame
24 hours after and 6 days after surgery
Title
Subjective pain assessment
Description
Visual analog pain scale
Time Frame
6 days after surgery

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male inguinal hernia
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University hospital of Split
City
Split
State/Province
Splitsko Dalmatinska Županija
ZIP/Postal Code
21000
Country
Croatia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Just investigators have insight in patient data, no such data (names and private data) would be written in the study for publishing
Citations:
PubMed Identifier
30511312
Citation
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.
Results Reference
derived

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Inflammatory Stress Response in Pediatric Inguinal Hernia Repair

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