Surgery Clinical Trial
Official title:
Comparison of Inflammatory Stress Response Between Laparoscopic and Open Approach for Pediatric Inguinal Hernia Repair
Verified date | December 2018 |
Source | University Hospital of Split |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Croatia | University hospital of Split | Split | Splitsko Dalmatinska Županija |
Lead Sponsor | Collaborator |
---|---|
University Hospital of Split |
Croatia,
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 |
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