Inguinal HerniaNCT02336256
Plasma Total Antioxidant Status and Thiobarbituric Acid-reacting Substances in Patients With Inguinal Hernia
A study testing Procedures of hernia repair. in people with Inguinal Hernia, run by Poznan University of Medical Sciences.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Procedures of hernia repair.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with inguinal hernia.
Who cannot join
- Patients with acute disease and severe chronic disorder.
About this study
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)
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.
Read the 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%)
- Conditions
- Inguinal Hernia
- Being tested
- Procedures of hernia repair.
- Keywords
- inguinal hernia repair, totally extraperitoneal (TEP), single incision laparoscopic surgery (SILS), plasma total antioxidant status
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedures of hernia repair.Procedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| TEP SILS | Experimental | Procedures of hernia repair. Patients operated due to inguinal hernia using modified single incision laparoscopic surgery (SILS) methods. Receives: Procedure: Procedures of hernia repair. |
| Typical TEP | Active comparator | Procedures of hernia repair. Patients operated due to inguinal hernia using typical totally extra peritoneal. Receives: Procedure: Procedures of hernia repair. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of changes in the concentration of Total antioxidant status, Thiobarbituric acid-reacting substances.
Measured: Before treatment
Secondary outcomes (1)
Assessment of changes in the concentration of Total antioxidant status, Thiobarbituric acid-reacting substances.
Measured: One day after the laparoscopic surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2015 (estimated)
- Study startJan 2013
- Primary completionApr 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacek Białecki, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336256
- Sponsor's protocol ID
- JB-1
- Status last verified
- Jan 2015
- First submitted
- 16 Dec 2014
- Last updated
- 12 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02336256
- Acronym / sponsor ID
- JB-1
- Conditions
- Inguinal Hernia
- Keywords
- inguinal hernia repair, totally extraperitoneal (TEP), single incision laparoscopic surgery (SILS), plasma total antioxidant status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 12 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEP SILS | Experimental | Procedure: Procedures of hernia repair.Procedures of hernia repair. Patients operated due to inguinal hernia using modified single incision laparoscopic surgery (SILS) methods. |
| Typical TEP | Active comparator | Procedure: Procedures of hernia repair.Procedures of hernia repair. Patients operated due to inguinal hernia using typical totally extra peritoneal. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with inguinal hernia.
Key exclusion criteria (1 listed)
- Patients with acute disease and severe chronic disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Procedure or surgery | TEP SILS, Typical TEP |
Primary outcome
Assessment of changes in the concentration of Total antioxidant status, Thiobarbituric acid-reacting substances.
Time frame: Before treatment
1 secondary outcome
Assessment of changes in the concentration of Total antioxidant status, Thiobarbituric acid-reacting substances.
Time frame: One day after the laparoscopic surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Procedures of hernia repair. in people with Inguinal Hernia, run by Poznan University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of changes in the concentration of Total antioxidant status, Thiobarbituric acid-reacting substances. (time frame: Before treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2015.