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Inflammatory Stress Response in Pediatric Inguinal Hernia Repair

NCT ID: NCT03203343

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-06-25

Brief Summary

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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

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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.

Conditions

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

Keywords

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Inguinal Hernia, Indirect Children, Only Inflammatory Response Surgery Interleukin-6 Tumor necrosis factor alpha C reactive protein Leukocytes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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PIRS group

Patients operated laparoscopically - PIRS technique

Group Type ACTIVE_COMPARATOR

Operation - PIRS

Intervention Type PROCEDURE

Operation by its known design for PIRS group

Marcy group

Patients operated by open modified Marcy technique

Group Type ACTIVE_COMPARATOR

Operation - MARCY

Intervention Type PROCEDURE

Operation by its known design for MARCY group

Interventions

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Operation - PIRS

Operation by its known design for PIRS group

Intervention Type PROCEDURE

Operation - MARCY

Operation by its known design for MARCY group

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital of Split

OTHER

Sponsor Role lead

Responsible Party

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Miro Jukić

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University hospital of Split

Split, Split-Dalmatia County, Croatia

Site Status

Countries

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Croatia

References

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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.

Reference Type DERIVED
PMID: 30511312 (View on PubMed)

Other Identifiers

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University hospital of Split

Identifier Type: -

Identifier Source: org_study_id