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临床试验/NCT02336256
NCT02336256已完成不适用

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)

Poznan University of Medical Sciences0 个研究点目标入组 34 人开始时间: 2013年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
主要终点
Assessment of changes in the concentration of Total antioxidant status, Thiobarbituric acid-reacting substances.

研究概览

简要总结

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.

详细描述

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%)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Patients with inguinal hernia.

排除标准

  • •Patients with acute disease and severe chronic disorder.

研究组 & 干预措施

TEP SILS

Experimental

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

干预措施: Procedures of hernia repair. (Procedure)

Typical TEP

Active Comparator

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

干预措施: Procedures of hernia repair. (Procedure)

结局指标

主要结局

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

时间窗: Before treatment

次要结局

  • Assessment of changes in the concentration of Total antioxidant status, Thiobarbituric acid-reacting substances.(One day after the laparoscopic surgery)

研究者

发起方
Poznan University of Medical Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jacek Białecki

MD, PhD

Poznan University of Medical Sciences

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