NCT03203343

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 29, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2018

Completed
Last Updated

December 19, 2018

Status Verified

December 1, 2018

Enrollment Period

1.1 years

First QC Date

June 16, 2017

Last Update Submit

December 17, 2018

Conditions

Inguinal Hernia, IndirectChildren, OnlyInflammatory ResponseSurgeryInterleukin-6Tumor Necrosis Factor AlphaC Reactive ProteinWhite Blood Cell Count, Leukocytes

Keywords

Inguinal Hernia, IndirectChildren, OnlyInflammatory ResponseSurgeryInterleukin-6Tumor necrosis factor alphaC reactive proteinLeukocytes

Outcome Measures

Primary Outcomes (4)

  • 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

    3 measurements: preoperative, 24 hours after and 6 days after surgery

  • 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

    3 measurements: preoperative, 24 hours after and 6 days after surgery

  • 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

    3 measurements: preoperative, 24 hours after and 6 days after surgery

  • 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

    3 measurements: preoperative, 24 hours after and 6 days after surgery

Secondary Outcomes (2)

  • Subjective pain assessment

    24 hours after and 6 days after surgery

  • Subjective pain assessment

    6 days after surgery

Study Arms (2)

PIRS group

ACTIVE COMPARATOR

Patients operated laparoscopically - PIRS technique

Procedure: Operation - PIRS

Marcy group

ACTIVE COMPARATOR

Patients operated by open modified Marcy technique

Procedure: Operation - MARCY

Interventions

Operation - PIRSPROCEDURE

Operation by its known design for PIRS group

PIRS group
Operation - MARCYPROCEDURE

Operation by its known design for MARCY group

Marcy group

Eligibility Criteria

Age3 Years - 7 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale inguinal hernia
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • male children with inguinal hernia at age of 3 to 7
  • one-sided inguinal hernia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital of Split

Split, Split-Dalmatia County, 21000, Croatia

Location

Related Publications (1)

  • 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: 30511312DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

June 16, 2017

First Posted

June 29, 2017

Study Start

May 1, 2017

Primary Completion

June 1, 2018

Study Completion

June 25, 2018

Last Updated

December 19, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will share

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

Locations

CR(1)