Clinical trial NCT03203343: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University Hospital of Split
Sponsor class: OTHER
First posted: 2017-06-29
Enrollment: 32
Sex: MALE
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in inflammatory stress response (IL6)
timeFrame: 3 measurements: preoperative, 24 hours after and 6 days after surgery
measure: Change in inflammatory stress response (CRP)
timeFrame: 3 measurements: preoperative, 24 hours after and 6 days after surgery
measure: Change in inflammatory stress response (TNF alpha)
timeFrame: 3 measurements: preoperative, 24 hours after and 6 days after surgery
measure: Change in inflammatory stress response (Leukocytes WBC)
timeFrame: 3 measurements: preoperative, 24 hours after and 6 days after surgery
Secondary outcomes:
measure: Subjective pain assessment
timeFrame: 24 hours after and 6 days after surgery
measure: Subjective pain assessment
timeFrame: 6 days after surgery
Other outcomes:
Locations:
city: Split
country: Croatia
facility: University hospital of Split
state: Splitsko Dalmatinska Županija
Study officials:
References:
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.