Hernia, InguinalNCT05420376
Comparison of Whole Mesh and Split Mesh Use in Laparoscopic Inguinal Hernia Repair
A study testing Split Mesh in people with Hernia, Inguinal, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
At least 80 patients who will undergo laparoscopic inguinal hernia repair surgery will be randomized into 2 groups. For the patients in the first group, the whole mesh will be laid on the area without being fixed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hernia, Inguinal
- What is being tested?
- Split Mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jun 2022to 16 Jun 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical or/and radiological diagnosed primary inguinal hernia
- TEP or TAPP surgical methods
Who cannot join
- Recurrent hernias
- Patients with previous groin operations on same side
- Pregnant women
- Patients who did not accept to participate in the study
- ASA score of 3 or higher,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Training and Research Hospital
Istanbul
Erol AYDIN, MD, +90 5322546001, erolay@gmail.com
About this study
Official title: Prospective Comparison of Whole Mesh and Split Mesh Use in Patient Groups Undergoing Laparoscopic Inguinal Hernia Repair
At least 80 patients who will undergo laparoscopic inguinal hernia repair surgery will be randomized into 2 groups. For the patients in the first group, the whole mesh will be laid on the area without being fixed. The patients in the second group will be given a mesh of the same size, but partially divided horizontally and wrapped around the spermatic cord. Demographic data of patients in both groups, quality of life data(Carolinas Comfort Scale) at postoperative 1st, 7th, 30th, 3rd and 6th months, postoperative pain (VAS values), clinical seroma rate, recurrence and other complications will be monitored. When the desired number of patients and follow-up period are reached, the data in the 2 groups will be compared.
- Conditions
- Hernia, Inguinal
- Being tested
- Split Mesh
- Keywords
- Laparoscopic Inguinal Hernia, Laparoscopic Hernia, Whole Mesh, Split Mesh, TAP, TEPP, 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.
Split MeshProcedure or surgery
Also called Whole mesh
TEP repair of inguinal hernias using either split or whole mesh
| Study group | Role | What they receive |
|---|---|---|
| Whole Mesh | Active comparator | For the patients in the first group, the whole patch will be laid on the area without being fixed. Receives: Procedure: Split Mesh |
| Split Mesh | Active comparator | The patients in the second group will be given a patch of the same size, but partially divided horizontally and wrapped around the spermatic cord. Receives: Procedure: Split Mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carolinas Comfort Scale values
Differences in postoperative pain and quality of life(Carolinas Comfort Scale at first month) in patients who use whole meshes and those who use split meshes.
Measured: 6 month
Recurrence rates
Differences in recurrence rates in patients who use whole meshes and those who use split meshes.
Measured: 6 month
Secondary outcomes (1)
Recurrence rates
Difference in recurrence rates at 6 months in patients who use whole meshes and those who use split meshes.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start16 Jun 2022
- Primary completion16 May 2023 (estimated)
- Study completion16 Jun 2023 (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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Erol Aydın, Istanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420376
- Sponsor's protocol ID
- 569874
- Status last verified
- Jul 2022
- First submitted
- 20 May 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of Whole Mesh and Split Mesh Use in Patient Groups Undergoing Laparoscopic Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT05420376
- Acronym / sponsor ID
- 569874
- Conditions
- Hernia, Inguinal
- Keywords
- Laparoscopic Inguinal Hernia, Laparoscopic Hernia, Whole Mesh, Split Mesh, TAP, TEPP, Inguinal hernia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 16 May 2023 (estimated)
- Study completion
- 16 Jun 2023 (estimated)
- First posted
- 15 Jun 2022 (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.
At least 80 patients who will undergo laparoscopic inguinal hernia repair surgery will be randomized into 2 groups. For the patients in the first group, the whole mesh will be laid on the area without being fixed. The patients in the second group will be given a mesh of the same size, but partially divided horizontally and wrapped around the spermatic cord. Demographic data of patients in both groups, quality of life data(Carolinas Comfort Scale) at postoperative 1st, 7th, 30th, 3rd and 6th months, postoperative pain (VAS values), clinical seroma rate, recurrence and other complications will be monitored. When the desired number of patients and follow-up period are reached, the data in the 2 groups will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole Mesh | Active comparator | Procedure: Split MeshFor the patients in the first group, the whole patch will be laid on the area without being fixed. |
| Split Mesh | Active comparator | Procedure: Split MeshThe patients in the second group will be given a patch of the same size, but partially divided horizontally and wrapped around the spermatic cord. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical or/and radiological diagnosed primary inguinal hernia
- TEP or TAPP surgical methods
Key exclusion criteria (5 listed)
- Recurrent hernias
- Patients with previous groin operations on same side
- Pregnant women
- Patients who did not accept to participate in the study
- ASA score of 3 or higher,
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 |
|---|---|---|
| Split MeshAlso: Whole meshTEP repair of inguinal hernias using either split or whole mesh | Procedure or surgery | Split Mesh, Whole Mesh |
Primary outcome
Carolinas Comfort Scale values
Time frame: 6 month
Differences in postoperative pain and quality of life(Carolinas Comfort Scale at first month) in patients who use whole meshes and those who use split meshes.
Recurrence rates
Time frame: 6 month
Differences in recurrence rates in patients who use whole meshes and those who use split meshes.
1 secondary outcome
Recurrence rates
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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 Split Mesh in people with Hernia, Inguinal, run by Istanbul Training and Research Hospital 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 5 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 20 Jul 2022. 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 Erol Aydın, MD (+905322546001, erolay@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carolinas Comfort Scale values (time frame: 6 month). The study lists 2 primary outcomes in all. 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 20 Jul 2022; AzTrials last refreshed its copy on 6 Nov 2026.