Hernia, InguinalNCT03421925
Effects of Using Divided Mesh and Using a Non Divided Mesh on Testicular Blood Flow and Volume in Laparoscopic Hernia Repair
A study testing Laparoscopic totally extraperitoneal procedure for inguinal hernia in people with Hernia, Inguinal, run by Okan University at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic inguinal hernia repair techniques has been compared with the open techniques in several studies. However, no one studied about the different uses of the same type of mesh on the same surgical technique, and effects of this different use on testicular volume and blood flow. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hernia, Inguinal
- What is being tested?
- Laparoscopic totally extraperitoneal procedure for inguinal hernia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2018to 1 Feb 2020
- 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 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with unilateral inguinal hernia Male patients
- -
Who cannot join
- Patients have femoral hernia Patients have bilateral inguinal hernia Patients have recurrent inguinal hernia Female patients Patients with history of pelvic surgery Patients with history of pelvic major trauma Patients with history of pelvic radiotherapy Patients have previous scrotal trauma or surgery history Patients have heavy cardiac diseases, pulmonary diseases Patients have benign prostate hyperplasia Patients have history of incarceration of inguinal hernia
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Okan University
Istanbul, 34734
Murat Ferhat Ferhatoglu, M.D., +905553214793, ferhatferhatoglu@gmail.com
About this study
Laparoscopic inguinal hernia repair techniques has been compared with the open techniques in several studies. However, no one studied about the different uses of the same type of mesh on the same surgical technique, and effects of this different use on testicular volume and blood flow. The objective of this study is to investigate the effects at 6 months of the divided and non divided mesh in laparoscopic totally extraperitoneal hernia repair technique on testicular volume and blood flow by use of Doppler Ultrasonography
- Conditions
- Hernia, Inguinal
- Being tested
- Laparoscopic totally extraperitoneal procedure for inguinal hernia
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic totally extraperitoneal procedure for inguinal herniaProcedure or surgery
Laparoscopic totally extraperitoneal procedure for inguinal hernia is a technique that is done by not entering the peritoneal cavity
| Study group | Role | What they receive |
|---|---|---|
| Divided mesh group | Other | In this group, surgeon will use a mesh divided in to two legs in laparoscopic totally extraperitoneal repair Receives: Procedure: Laparoscopic totally extraperitoneal procedure for inguinal hernia |
| Non divided mesh group | Other | In this group, surgeon will use a non divided mesh in laparoscopic totally extraperitoneal repair Receives: Procedure: Laparoscopic totally extraperitoneal procedure for inguinal hernia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testicular volume
Measured: 6 months
Secondary outcomes (1)
Testicular artery blood flow
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start1 Feb 2018 (estimated)
- Primary completion1 Feb 2019 (estimated)
- Study completion1 Feb 2020 (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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Ferhat Ferhatoglu, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421925
- Sponsor's protocol ID
- OkanU
- Status last verified
- Feb 2018
- First submitted
- 26 Jan 2018
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Using Divided Mesh and Using a Non Divided Mesh on Testicular Blood Flow and Volume in Laparoscopic Hernia Repair
- ClinicalTrials.gov ID
- NCT03421925
- Acronym / sponsor ID
- OkanU
- Conditions
- Hernia, Inguinal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (estimated)
- Primary completion
- 1 Feb 2019 (estimated)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 5 Feb 2018 (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.
Laparoscopic inguinal hernia repair techniques has been compared with the open techniques in several studies. However, no one studied about the different uses of the same type of mesh on the same surgical technique, and effects of this different use on testicular volume and blood flow. The objective of this study is to investigate the effects at 6 months of the divided and non divided mesh in laparoscopic totally extraperitoneal hernia repair technique on testicular volume and blood flow by use of Doppler Ultrasonography
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Divided mesh group | Other | Procedure: Laparoscopic totally extraperitoneal procedure for inguinal herniaIn this group, surgeon will use a mesh divided in to two legs in laparoscopic totally extraperitoneal repair |
| Non divided mesh group | Other | Procedure: Laparoscopic totally extraperitoneal procedure for inguinal herniaIn this group, surgeon will use a non divided mesh in laparoscopic totally extraperitoneal repair |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with unilateral inguinal hernia Male patients
- -
Key exclusion criteria (2 listed)
- Patients have femoral hernia Patients have bilateral inguinal hernia Patients have recurrent inguinal hernia Female patients Patients with history of pelvic surgery Patients with history of pelvic major trauma Patients with history of pelvic radiotherapy Patients have previous scrotal trauma or surgery history Patients have heavy cardiac diseases, pulmonary diseases Patients have benign prostate hyperplasia Patients have history of incarceration of inguinal hernia
- -
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 |
|---|---|---|
| Laparoscopic totally extraperitoneal procedure for inguinal herniaLaparoscopic totally extraperitoneal procedure for inguinal hernia is a technique that is done by not entering the peritoneal cavity | Procedure or surgery | Divided mesh group, Non divided mesh group |
Primary outcome
Testicular volume
Time frame: 6 months
1 secondary outcome
Testicular artery blood flow
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic totally extraperitoneal procedure for inguinal hernia in people with Hernia, Inguinal, run by Okan University 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 2 inclusion and 2 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 5 Feb 2018. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Testicular volume (time frame: 6 months). 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 5 Feb 2018.