Plasma Total Antioxidant Status and Thiobarbituric Acid-reacting Substances in Patients With Inguinal Hernia

January 7, 2015 updated by: Jacek Białecki, Poznan University of Medical Sciences

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with inguinal hernia.

Exclusion Criteria:

  • Patients with acute disease and severe chronic disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TEP SILS
Procedures of hernia repair. Patients operated due to inguinal hernia using modified single incision laparoscopic surgery (SILS) methods.
Procedure: Procedures of hernia repair.
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).
Active Comparator: Typical TEP
Procedures of hernia repair. Patients operated due to inguinal hernia using typical totally extra peritoneal.
Procedure: Procedures of hernia repair.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of changes in the concentration of Total antioxidant status, Thiobarbituric acid-reacting substances.
Time Frame: Before treatment
Before treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of changes in the concentration of Total antioxidant status, Thiobarbituric acid-reacting substances.
Time Frame: One day after the laparoscopic surgery
One day after the laparoscopic surgery

Other Outcome Measures

Outcome Measure
Time Frame
Assessment of changes in the concentration of Total antioxidant status, Thiobarbituric acid-reacting substances.
Time Frame: Four days after the laparoscopic surgery
Four days after the laparoscopic surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poznan University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

December 16, 2014

First Submitted That Met QC Criteria

January 7, 2015

First Posted (Estimate)

January 12, 2015

Study Record Updates

Last Update Posted (Estimate)

January 12, 2015

Last Update Submitted That Met QC Criteria

January 7, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JB-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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