Hernia, InguinalNCT03355950
ASA Levels in TEP and Lichtenstein Repair Patients
A study testing Lichtenstein Repair and TEP Repair in people with Hernia, Inguinal, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to determine and compare the possible affects of two different inguinal hernia repair technique (TEP and Lichtenstein) on serum ASA levels. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men only
- Conditions the study is for
- Hernia, Inguinal
- What is being tested?
- Lichtenstein Repair and TEP Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2017to Aug 2018
- 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 20 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- to accept the terms of the randomization and all study
- to have unilateral inguinal hernia and set for an inguinal hernia repair
- to be a father
Who cannot join
- to have any kind of autoimmune disorders
- any kind of infertility history
- to have a history of inguinal and/or genital surgery and/or trauma
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Numune Training and Research Hospital
Ankara, 06100
Selami Ilgaz Kayılıoğlu, MD, +905332036595, kayilioglu@yahoo.com
About this study
Official title: Comparison of Anti-sperm Antibody Levels in Inguinal Hernia Patients Who Undergo Totally Extra-peritoneal and Lichtenstein Repair
The purpose of this study is to determine and compare the possible affects of two different inguinal hernia repair technique (TEP and Lichtenstein) on serum ASA levels.
Read the detailed description
Antisperm antibody levels are thought to be indirect indicators of spermatic duct injuries. The investigators' ultimate goal is to draw a conclusion about the effect of the type of surgery on spermatic duct integrity. The investigators are going to collect serum samples from inguinal hernia patients before and after surgery. The investigators aim to assess the effect of surgery on antisperm antibody levels of patients who undergo Licthenstein and TEP repair. Preoperative antisperm antibody levels will serve as control levels for each patient group.
- Conditions
- Hernia, Inguinal
- Being tested
- Lichtenstein Repair, TEP Repair
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lichtenstein RepairProcedure or surgery
Well defined Lichtenstein Repair for inguinal hernias
TEP RepairProcedure or surgery
Laparoscopic totally extraperitoneal repair for inguianal hernias
| Study group | Role | What they receive |
|---|---|---|
| TEP group | Active comparator | Patients who undergo totally extraperitoneal hernia repair, TEP Repair. Receives: Procedure: TEP Repair |
| Lichtenstein group | Active comparator | Patients who undergo Lichtenstein repair. Receives: Procedure: Lichtenstein Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Anti-sperm antibody levels after inguinal hernia surgery
Samples will be collected before hernia surgery and three months after surgery
Measured: Three months for each patient
Secondary outcomes (1)
Comparison of Anti-sperm antibody levels between inguinal hernia patients who have undergone laparoscopic totally extraperitoneal repair and Lichtenstein repair techniques
Measured: 2 years anticipated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study startJan 2017
- Primary completionJan 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, InguinalStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Faruk Coskun, MD, Prof, Study director, Ankara Numune Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355950
- Sponsor's protocol ID
- E-16-1019
- Status last verified
- Nov 2017
- First submitted
- 30 Jan 2017
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Anti-sperm Antibody Levels in Inguinal Hernia Patients Who Undergo Totally Extra-peritoneal and Lichtenstein Repair
- ClinicalTrials.gov ID
- NCT03355950
- Acronym / sponsor ID
- E-16-1019
- Conditions
- Hernia, Inguinal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 29 Nov 2017 (actual)
- 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.
The purpose of this study is to determine and compare the possible affects of two different inguinal hernia repair technique (TEP and Lichtenstein) on serum ASA levels.
Detailed description
Antisperm antibody levels are thought to be indirect indicators of spermatic duct injuries. The investigators' ultimate goal is to draw a conclusion about the effect of the type of surgery on spermatic duct integrity. The investigators are going to collect serum samples from inguinal hernia patients before and after surgery. The investigators aim to assess the effect of surgery on antisperm antibody levels of patients who undergo Licthenstein and TEP repair. Preoperative antisperm antibody levels will serve as control levels for each patient group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEP group | Active comparator | Procedure: TEP RepairPatients who undergo totally extraperitoneal hernia repair, TEP Repair. |
| Lichtenstein group | Active comparator | Procedure: Lichtenstein RepairPatients who undergo Lichtenstein repair. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- to accept the terms of the randomization and all study
- to have unilateral inguinal hernia and set for an inguinal hernia repair
- to be a father
Key exclusion criteria (3 listed)
- to have any kind of autoimmune disorders
- any kind of infertility history
- to have a history of inguinal and/or genital surgery and/or trauma
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 |
|---|---|---|
| Lichtenstein RepairWell defined Lichtenstein Repair for inguinal hernias | Procedure or surgery | Lichtenstein group |
| TEP RepairLaparoscopic totally extraperitoneal repair for inguianal hernias | Procedure or surgery | TEP group |
Primary outcome
Change from baseline Anti-sperm antibody levels after inguinal hernia surgery
Time frame: Three months for each patient
Samples will be collected before hernia surgery and three months after surgery
1 secondary outcome
Comparison of Anti-sperm antibody levels between inguinal hernia patients who have undergone laparoscopic totally extraperitoneal repair and Lichtenstein repair techniques
Time frame: 2 years anticipated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
- Individual participant dataSharing planned: No
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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.
Faruk Coskun, MD, Prof study director
Ankara Numune Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lichtenstein Repair and TEP Repair in people with Hernia, Inguinal, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Selami Ilgaz Kayılıoğlu, MD (+90 533 203 6595, kayilioglu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Anti-sperm antibody levels after inguinal hernia surgery (time frame: Three months for each patient). 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 29 Nov 2017.