Inflammatory Stress Response in Pediatric Inguinal Hernia Repair

December 17, 2018 updated by: Miro Jukić, University Hospital of Split

Comparison of Inflammatory Stress Response Between Laparoscopic and Open Approach for 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
    • Splitsko Dalmatinska Županija
      • Split, Splitsko Dalmatinska Županija, Croatia, 21000
        • University Hospital of Split

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PIRS group
Patients operated laparoscopically - PIRS technique
Procedure: Operation - PIRS
Operation by its known design for PIRS group
Active Comparator: Marcy group
Patients operated by open modified Marcy technique
Procedure: Operation - MARCY
Operation by its known design for MARCY group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 measurements: preoperative, 24 hours after and 6 days after surgery
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 measurements: preoperative, 24 hours after and 6 days after surgery
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
3 measurements: preoperative, 24 hours after and 6 days after surgery
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
3 measurements: preoperative, 24 hours after and 6 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective pain assessment
Time Frame: 24 hours after and 6 days after surgery
Visual analog pain scale
24 hours after and 6 days after surgery
Subjective pain assessment
Time Frame: 6 days after surgery
Visual analog pain scale
6 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Split

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 25, 2018

Study Registration Dates

First Submitted

June 16, 2017

First Submitted That Met QC Criteria

June 27, 2017

First Posted (Actual)

June 29, 2017

Study Record Updates

Last Update Posted (Actual)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 17, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • University hospital of Split

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Just investigators have insight in patient data, no such data (names and private data) would be written in the study for publishing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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