HerniaherniaNCT01578538
Safety of Mesh Used Repairs in Emergency Abdominal Wall Hernias. Prospective Randomized Multicenter Trial
A study testing inguinal hernia repair in people with Hernia, run by SB Istanbul Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Repairing of emergency (strangulated) abdominal wall hernias with mesh may cause infective complications. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hernia
- What is being tested?
- inguinal hernia repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2012to Jun 2016
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Older than 16 years old,
- Strangulated abdominal wall hernia
- No any contrindications to operation
Who cannot join
- Younger than 16 years old,
- Non-strangulated abdominal wall hernis
- Any causes of contrindications to operation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem Vakif University
Istanbul, Marmara, 34543
adnan yuksel, prof, 904531700, ayuksel@bezmialem.edu.tr
erhan aysan, prof
About this study
Official title: Mesh Used Repairs in Emergency Abdominal Wall Hernias
Repairing of emergency (strangulated) abdominal wall hernias with mesh may cause infective complications.
Read the detailed description
Repairing of emergency (strangulated) abdominal wall hernias with mesh is controversary. Strangulated abdominal hernias are not clean surgical wounds so applying prostetic materials such as meshes are problematic. Using of prostetic materials in un-clean wounds (clean contaminated, contaminated and dirty) is not proposed. But in surgical practice meshed surgical repair techniques are using largeley. In this multicenter study we try to find the answer for emergency hernia repairs meshed or not.
- Conditions
- Hernia
- Being tested
- inguinal hernia repair
- Keywords
- hernia, abdominal, strangulation, emergency, wall
- Medical subject headings
- Hernia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inguinal hernia repairProcedure or surgery
strangulated hernias will be repaired surgically
| Study group | Role | What they receive |
|---|---|---|
| mesh used repair | Active comparator | mesh used hernia repair will be perform Receives: Procedure: inguinal hernia repair |
| nonmesh | Active comparator | nonmesh hernia repair techniques will be used Receives: Procedure: inguinal hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound infection
surgical wound infection is the primary outcome measure of this trial
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startFeb 2012
- Primary completionJun 2014 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SB Istanbul Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erhan Aysan, SB Istanbul Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578538
- Sponsor's protocol ID
- herni
- Other IDs
- travma & emergency surgery
- Acronym
- hernia
- Status last verified
- Apr 2012
- First submitted
- 13 Apr 2012
- Last updated
- 17 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesh Used Repairs in Emergency Abdominal Wall Hernias
- ClinicalTrials.gov ID
- NCT01578538
- Acronym / sponsor ID
- hernia / herni
- Conditions
- Hernia
- Keywords
- hernia, abdominal, strangulation, emergency, wall
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- SB Istanbul Education and Research HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 17 Apr 2012 (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.
Repairing of emergency (strangulated) abdominal wall hernias with mesh may cause infective complications.
Detailed description
Repairing of emergency (strangulated) abdominal wall hernias with mesh is controversary. Strangulated abdominal hernias are not clean surgical wounds so applying prostetic materials such as meshes are problematic. Using of prostetic materials in un-clean wounds (clean contaminated, contaminated and dirty) is not proposed. But in surgical practice meshed surgical repair techniques are using largeley. In this multicenter study we try to find the answer for emergency hernia repairs meshed or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mesh used repair | Active comparator | Procedure: inguinal hernia repairmesh used hernia repair will be perform |
| nonmesh | Active comparator | Procedure: inguinal hernia repairnonmesh hernia repair techniques will be used |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Older than 16 years old,
- Strangulated abdominal wall hernia
- No any contrindications to operation
Key exclusion criteria (3 listed)
- Younger than 16 years old,
- Non-strangulated abdominal wall hernis
- Any causes of contrindications to operation
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 |
|---|---|---|
| inguinal hernia repairstrangulated hernias will be repaired surgically | Procedure or surgery | mesh used repair, nonmesh |
Primary outcome
wound infection
Time frame: six months
surgical wound infection is the primary outcome measure of this trial
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2012.
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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 inguinal hernia repair in people with Hernia, run by SB Istanbul Education 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 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 17 Apr 2012. 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?
wound infection (time frame: six 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 17 Apr 2012.