Plasma Total Antioxidant Status and Thiobarbituric Acid-reacting Substances in Patients With Inguinal Hernia
Primary Purpose
Inguinal Hernia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Procedures of hernia repair.
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia focused on measuring inguinal hernia repair, totally extraperitoneal (TEP), single incision laparoscopic surgery (SILS), plasma total antioxidant status
Eligibility Criteria
Inclusion Criteria:
- Patients with inguinal hernia.
Exclusion Criteria:
- Patients with acute disease and severe chronic disorder.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TEP SILS
Typical TEP
Arm Description
Procedures of hernia repair. Patients operated due to inguinal hernia using modified single incision laparoscopic surgery (SILS) methods.
Procedures of hernia repair. Patients operated due to inguinal hernia using typical totally extra peritoneal.
Outcomes
Primary Outcome Measures
Assessment of changes in the concentration of Total antioxidant status, Thiobarbituric acid-reacting substances.
Secondary Outcome Measures
Assessment of changes in the concentration of Total antioxidant status, Thiobarbituric acid-reacting substances.
Full Information
NCT ID
NCT02336256
First Posted
December 16, 2014
Last Updated
January 7, 2015
Sponsor
Poznan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02336256
Brief Title
Plasma Total Antioxidant Status and Thiobarbituric Acid-reacting Substances in Patients With Inguinal Hernia
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Poznan University of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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%)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
inguinal hernia repair, totally extraperitoneal (TEP), single incision laparoscopic surgery (SILS), plasma total antioxidant status
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TEP SILS
Arm Type
Experimental
Arm Description
Procedures of hernia repair. Patients operated due to inguinal hernia using modified single incision laparoscopic surgery (SILS) methods.
Arm Title
Typical TEP
Arm Type
Active Comparator
Arm Description
Procedures of hernia repair. Patients operated due to inguinal hernia using typical totally extra peritoneal.
Intervention Type
Procedure
Intervention Name(s)
Procedures of hernia repair.
Intervention 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).
Primary Outcome Measure Information:
Title
Assessment of changes in the concentration of Total antioxidant status, Thiobarbituric acid-reacting substances.
Time Frame
Before treatment
Secondary Outcome Measure Information:
Title
Assessment of changes in the concentration of Total antioxidant status, Thiobarbituric acid-reacting substances.
Time Frame
One day after the laparoscopic surgery
Other Pre-specified Outcome Measures:
Title
Assessment of changes in the concentration of Total antioxidant status, Thiobarbituric acid-reacting substances.
Time Frame
Four days after the laparoscopic surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with inguinal hernia.
Exclusion Criteria:
Patients with acute disease and severe chronic disorder.
12. IPD Sharing Statement
Learn more about this trial
Plasma Total Antioxidant Status and Thiobarbituric Acid-reacting Substances in Patients With Inguinal Hernia
We'll reach out to this number within 24 hrs