Incisional HerniaIH01NCT02314091
Long Term Results of Randomized Prospective Comparison of Onlay and Sublay Mesh Repair Techniques for Incisional Hernia
A study testing onlay mesh hernioplasty in people with Incisional Hernia, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
Trial summary
Randomised prospective comparison of onlay and sublay mesh repair techniques in incisional hernia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- onlay mesh hernioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2011to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Incisional hernia
- Acceptance of the trial
Who cannot join
- BMI>40
- ASA score of 4
- Severe pulmonary or cardiac disease
Trial locations and contacts
1 site in 1 country.
About this study
Randomised prospective comparison of onlay and sublay mesh repair techniques in incisional hernia
- Conditions
- Incisional Hernia
- Being tested
- onlay mesh hernioplasty
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
onlay mesh hernioplastyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Onlay | Experimental | Onlay mesh repair group Receives: Procedure: onlay mesh hernioplasty |
| sublay | Experimental | Sublay mesh repair group Receives: Procedure: onlay mesh hernioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study startJan 2011
- Primary completionSep 2012
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, barış sevinç, Konya Meram State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02314091
- Sponsor's protocol ID
- KonyaTRH
- Acronym
- IH01
- Status last verified
- Dec 2014
- First submitted
- 8 Dec 2014
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Results of Randomized Prospective Comparison of Onlay and Sublay Mesh Repair Techniques for Incisional Hernia
- ClinicalTrials.gov ID
- NCT02314091
- Acronym / sponsor ID
- IH01 / KonyaTRH
- Conditions
- Incisional Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Dec 2014 (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.
Randomised prospective comparison of onlay and sublay mesh repair techniques in incisional hernia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Onlay | Experimental | Procedure: onlay mesh hernioplastyOnlay mesh repair group |
| sublay | Experimental | Procedure: onlay mesh hernioplastySublay mesh repair group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Incisional hernia
- Acceptance of the trial
Key exclusion criteria (3 listed)
- BMI>40
- ASA score of 4
- Severe pulmonary or cardiac disease
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 |
|---|---|---|
| onlay mesh hernioplasty | Procedure or surgery | Onlay, sublay |
Primary outcome
recurrence
Time frame: 3 years
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 10 Dec 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing onlay mesh hernioplasty in people with Incisional Hernia, run by Konya Meram State 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 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: finished, as of the sponsor's last update on 10 Dec 2014. 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?
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?
recurrence (time frame: 3 years). 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 10 Dec 2014.