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

NCT02336256 | Completed

• 1 other identifier: JB-1
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Inguinal Hernia

Keywords

inguinal hernia repair; totally extraperitoneal (TEP); single incision laparoscopic surgery (SILS); plasma total antioxidant status

Outcome Measures

Primary Outcomes (1)

• Assessment of changes in the concentration of Total antioxidant status, Thiobarbituric acid-reacting substances.

  Before treatment

Secondary Outcomes (1)

• Assessment of changes in the concentration of Total antioxidant status, Thiobarbituric acid-reacting substances.

  One day after the laparoscopic surgery

Other Outcomes (1)

• Assessment of changes in the concentration of Total antioxidant status, Thiobarbituric acid-reacting substances.

  Four days after the laparoscopic surgery

Study Arms (2)

TEP SILS

EXPERIMENTAL

Procedures of hernia repair. Patients operated due to inguinal hernia using modified single incision laparoscopic surgery (SILS) methods.

Procedure: Procedures of hernia repair.

Typical TEP

ACTIVE COMPARATOR

Procedures of hernia repair. Patients operated due to inguinal hernia using typical totally extra peritoneal.

Procedure: Procedures of hernia repair.

Interventions

Procedures of hernia repair. PROCEDURE

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).

TEP SILS; Typical TEP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with inguinal hernia.

You may not qualify if:

• Patients with acute disease and severe chronic disorder.

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: January 12, 2015
• Study Start: January 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: July 1, 2014
• Last Updated: January 12, 2015

Record last verified: 2015-01