MeshNCT07196254
Lumber Hernia Repair Using Sandwich Mesh Technique
A study testing sandwich mesh technique in people with Mesh, run by Zagazig University at 1 site in Egypt.
Trial summary
Lumbar incisional hernia occurs after lumbar incision which is difficult to manage due deficient fascial aponeurosis and a proximity of the bonny boundaries, namely the iliac crest and the last rib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mesh
- What is being tested?
- sandwich mesh technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jan 2024to 14 Jan 2024
- 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
- • Patients older than 18 years old with primary inguinal hernia.
Who cannot join
- • Pregnancy or patients with bleeding tendency.
- Complicated hernia.
- Patients who are not fit for surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sandwich Mesh Repair for The Treatment Of Lumbar Incisional Hernia
Lumbar incisional hernia occurs after lumbar incision which is difficult to manage due deficient fascial aponeurosis and a proximity of the bonny boundaries, namely the iliac crest and the last rib. There is a need to evaluate sandwich mesh application, preperitoneal and onlay mesh, in the treatment of lumbar incisional hernia.
- Conditions
- Mesh
- Being tested
- sandwich mesh technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sandwich mesh techniqueProcedure or surgery
the hernia repair include using double mesh onlay and sublay
| Study group | Role | What they receive |
|---|---|---|
| hernia arm represent patients with lumbar abdominal hernia | Experimental | the patient that will undergo sandwich technique repair with onlay and sublay mesh Receives: Procedure: sandwich mesh technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
hernia recurrence rate detect by clinical examination and ultrasonography
Hernia recurrence is the most critical measure of surgical failure and is a direct indicator of the long-term effectiveness of the repair. A lower recurrence rate demonstrates the superiority of one surgical technique or material over another.
Measured: 6 months starting from the postoperative day 1
Secondary outcomes (1)
the rate of seroma formation as detected by subcutanous drain
the amount if seroma fluid will be estimated in ml as present un surgical subcutanous drain
Measured: 30 days from postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start14 Jan 2024
- Primary completion14 Jan 2024
- Study completion14 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MeshStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yasser Ali Orban, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196254
- Sponsor's protocol ID
- Sandwich Mesh Repair for The T
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Orban YA, Baz Y, Hegab YH. Sandwich mesh repair for the treatment of lumbar incisional hernia: a case series. BMC Surg. 2026 May 20;26(1):333. doi: 10.1186/s12893-026-03679-5.
PubMed 42163263
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sandwich Mesh Repair for The Treatment Of Lumbar Incisional Hernia
- ClinicalTrials.gov ID
- NCT07196254
- Acronym / sponsor ID
- Sandwich Mesh Repair for The T
- Conditions
- Mesh
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 14 Jan 2024 (actual)
- Primary completion
- 14 Jan 2024 (actual)
- Study completion
- 14 Jan 2024 (actual)
- First posted
- 29 Sep 2025 (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.
Lumbar incisional hernia occurs after lumbar incision which is difficult to manage due deficient fascial aponeurosis and a proximity of the bonny boundaries, namely the iliac crest and the last rib. There is a need to evaluate sandwich mesh application, preperitoneal and onlay mesh, in the treatment of lumbar incisional hernia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hernia arm represent patients with lumbar abdominal hernia | Experimental | Procedure: sandwich mesh techniquethe patient that will undergo sandwich technique repair with onlay and sublay mesh |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- • Patients older than 18 years old with primary inguinal hernia.
Key exclusion criteria (3 listed)
- • Pregnancy or patients with bleeding tendency.
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 |
|---|---|---|
| sandwich mesh techniquethe hernia repair include using double mesh onlay and sublay | Procedure or surgery | hernia arm represent patients with lumbar abdominal hernia |
Primary outcome
hernia recurrence rate detect by clinical examination and ultrasonography
Time frame: 6 months starting from the postoperative day 1
Hernia recurrence is the most critical measure of surgical failure and is a direct indicator of the long-term effectiveness of the repair. A lower recurrence rate demonstrates the superiority of one surgical technique or material over another.
1 secondary outcome
the rate of seroma formation as detected by subcutanous drain
Time frame: 30 days from postoperative day 1
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 29 Sep 2025.
- Derived from this study: PubMed 42163263Orban YA, Baz Y, Hegab YH. Sandwich mesh repair for the treatment of lumbar incisional hernia: a case series. BMC Surg. 2026 May 20;26(1):333. doi: 10.1186/s12893-026-03679-5.
- Individual participant dataSharing planned: Yes
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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 sandwich mesh technique in people with Mesh, run by Zagazig University at 1 site in Egypt.
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 1 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 29 Sep 2025. 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 Egypt. 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?
hernia recurrence rate detect by clinical examination and ultrasonography (time frame: 6 months starting from the postoperative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07196254, which also lists 1 linked publication.
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 Sep 2025.