Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-24 @ 11:32 PM
Ignite Modification Date: 2025-12-24 @ 11:32 PM
NCT ID: NCT02336256
Brief Summary: Introduction: Any form of trauma, including surgery is known to result in oxidative stress. Single incision laparoscopy is a step forward towards almost scarless surgery. It is also expected to result in a lower degree of free radicals generation and faster normalization of the organism's antioxidant capacity. Aim: The aim of the study was to assess a number of plasma oxidative stress markers in patients operated due to inguinal hernia using typical totally extra peritoneal (TEP) and modified single incision laparoscopic surgery (SILS) methods. Material and methods: Thirty-two consecutive patients with no acute disease and severe chronic disorder, were qualified for inguinal hernia laparoscopic surgery. All were caucasian males, aged 24-69 and they underwent one of two surgical approaches: totally extra-peritoneal repair (TEP) and single incision laparoscopic surgery (SILS). TEP patients created Group 1 (n= 17) and SILS patients formed Group 2 (n= 17). Total antioxidant status (TAS) and thiobarbituric acid-reacting substances (TBARS) were determined in three time points: before, one day and four days after the laparoscopic surgery.
Detailed Description: Thirty-two consecutive patients with no acute disease and severe chronic disorder were qualified for inguinal hernia laparoscopic surgery. All were caucasian males, aged 24-69 underwent one of two different surgical approaches: totally extra-peritoneal (TEP) repair and single incision laparoscopic surgery (SILS). TEP patients created Group 1 (n= 17) and SILS patients formed Group 2 (n= 17). Blood Sampling and Biochemical Analysis Ulnar venous blood samples were collected from the participants three times (fasting, between 6:00 and 7:00 AM): before (0), one day (1) and four days (2) after laparoscopic surgery. Baseline (0) blood samples were used for routine pre-operative laboratory assessment, including complete blood count, basic coagulation tests, C-reactive protein, glucose and electrolytes levels. Total antioxidant status (TAS) and thiobarbituric acid-reacting substances (TBARS) were determined in three time points: 0, 1 and 2 as described above. Spectrophotometry was used to measure TAS (RANDOX Laboratories, Crumlin, Antrim, UK) on Statfax 1904Plus (Awareness Technology, Palm City, FL) and TBARS according to the Okhawa method \[11\] (Sigma reagents, Germany) on Specord M40 (Carl-Zeiss, Germany). The intra- and inter-assay coefficients of variation were as follows: TAS (1.6 % and 3.7%), and TBARS (1.9% and 3.8%)
Study: NCT02336256
Study Brief:
Protocol Section: NCT02336256