Inflammatory Stress Response in Pediatric Inguinal Hernia Repair

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03203343
• Other study ID #: University hospital of Split
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: June 25, 2018

Study information

• Verified date: December 2018
• Source: University Hospital of Split
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 25, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 3 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Operation - PIRS
Operation by its known design for PIRS group
• Operation - MARCY
Operation by its known design for MARCY group

Locations

Country	Name	City	State
Croatia	University hospital of Split	Split	Splitsko Dalmatinska Županija

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Split

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Subjective pain assessment	Visual analog pain scale	24 hours after and 6 days after surgery
Secondary	Subjective pain assessment	Visual analog pain scale	6 days after surgery