Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-02-02 @ 12:09 AM
Study NCT ID:
NCT02336256
Status:
COMPLETED
Last Update Posted:
2015-01-12
First Post:
2014-12-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plasma Total Antioxidant Status and Thiobarbituric Acid-reacting Substances in Patients With Inguinal Hernia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-07', 'studyFirstSubmitDate': '2014-12-16', 'studyFirstSubmitQcDate': '2015-01-07', 'lastUpdatePostDateStruct': {'date': '2015-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assessment of changes in the concentration of Total antioxidant status, Thiobarbituric acid-reacting substances.', 'timeFrame': 'Four days after the laparoscopic surgery'}], 'primaryOutcomes': [{'measure': 'Assessment of changes in the concentration of Total antioxidant status, Thiobarbituric acid-reacting substances.', 'timeFrame': 'Before treatment'}], 'secondaryOutcomes': [{'measure': 'Assessment of changes in the concentration of Total antioxidant status, Thiobarbituric acid-reacting substances.', 'timeFrame': 'One day after the laparoscopic surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['inguinal hernia repair', 'totally extraperitoneal (TEP)', 'single incision laparoscopic surgery (SILS)', 'plasma total antioxidant status'], 'conditions': ['Inguinal Hernia']}, 'descriptionModule': {'briefSummary': "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.\n\nAim: 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.\n\nMaterial 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.", 'detailedDescription': '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).\n\nBlood 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.\n\nSpectrophotometry 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%)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with inguinal hernia.\n\nExclusion Criteria:\n\n* Patients with acute disease and severe chronic disorder.'}, 'identificationModule': {'nctId': 'NCT02336256', 'briefTitle': 'Plasma Total Antioxidant Status and Thiobarbituric Acid-reacting Substances in Patients With Inguinal Hernia', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Medical Sciences'}, 'officialTitle': 'Plasma Total Antioxidant Status and Thiobarbituric Acid-reacting Substances in Patients With Inguinal Hernia Operated by Totally Extraperitoneal (TEP) or Single Incision Laparoscopic Surgery (SILS)', 'orgStudyIdInfo': {'id': 'JB-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TEP SILS', 'description': 'Procedures of hernia repair. Patients operated due to inguinal hernia using modified single incision laparoscopic surgery (SILS) methods.', 'interventionNames': ['Procedure: Procedures of hernia repair.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Typical TEP', 'description': 'Procedures of hernia repair. Patients operated due to inguinal hernia using typical totally extra peritoneal.', 'interventionNames': ['Procedure: Procedures of hernia repair.']}], 'interventions': [{'name': 'Procedures of hernia repair.', 'type': 'PROCEDURE', 'description': 'We use two procedure: single incision laparoscopic surgery (SILS) and totally extra-peritoneal repair (TEP). SILS procedure used one approche - 10mm (experimental). TEP procedure used three approaches 2x5mm and 1x10mm (active comparator).', 'armGroupLabels': ['TEP SILS', 'Typical TEP']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Jacek Białecki', 'investigatorAffiliation': 'Poznan University of Medical Sciences'}}}}