Ventral HerniaNCT06867029
Onlay and Sublay Mesh in Treatment of Ventral Hernia
A study testing Onlay Mesh in people with Ventral Hernia, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Hernia is defined as aprotrusion of viscus or part of viscus usually within a peritonial sac through a defect in the abdominal wall. Ventral abdomenal hernias include all the hernias occuring through the anterior abdominal wall excluding groin hernias ( incisinal hernia, epigastric hernias, paraumbilical hernias… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- Onlay Mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 May 2023to 10 Jul 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ventral Hernia patients
Who cannot join
- Age below 18 years.
- Complicated hernia.
- Uncompensated heart or lung diseases, haemorrhagic disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Onlay and Sublay Mesh in Treatment of Ventral Hernia
Hernia is defined as aprotrusion of viscus or part of viscus usually within a peritonial sac through a defect in the abdominal wall.
Ventral abdomenal hernias include all the hernias occuring through the anterior abdominal wall excluding groin hernias ( incisinal hernia, epigastric hernias, paraumbilical hernias, umbilical and lumbar hernias)
Read the detailed description
Ventral hernia can be categorized according to their characteristic into reducible, irreducible or incarcerated , strangulated and recurrant ventral hernia.
The cause of a primary ventral hernia ia s far from completely understood, but it is undoubtedly multifactorial. familial prediposing play a role with increasing evidance of connective tissue disorders, they are considered as a leading cause of abdominal surgery and account for 2-10% of all abdomenal wall hernias .
Clinical data show that 52% of incisional hernias occur within 6 months postoperative as a result of excessive tension and inadeqate healing of aprevious incision.
The history of prothetic repair in abdominal wall hernias began in 1844 within the use of silver wire coils placed in the floor of groin to induce an inflammatory fibrosis . meny prosthetic material have been tried in hernia repair, but the two most common in current use are polypropylene mesh and expanded polytetrafluoroethylene.
The repair of ventral hernia varies from primary closure, primary closure with an onlay mesh reinforcement, sublay mesh placement, and intraperitonial mesh placement. Primary closure techniques are usually performed for smal fascial defects less than 5 cm in the greaters diameter
An onlay , usually of polyproptlene mesh is sutured to the anterior rectus sheeth after the fascial defect has been closed primary, thes type of repair has the potential advantage of keeping the mesh separeted from the abdomenal content by full abdominal muscle fascial wall thikness.
The sublay (retrorectus) placement of mesh, became popular in 1990, the recurence rates with this repair have been stated to be less than 10%.
- Conditions
- Ventral Hernia
- Being tested
- Onlay Mesh
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Onlay MeshProcedure or surgery
Also called Sublay Mesh
to compare between two techniques of mesh placement in uncomplicated ventral hernias, onlay (mesh on external oblique) versus sublay (mesh in the retromuscular space).
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | About 15 patients subjected to ventral hernia of onlay mesh procedure (mesh on external oblique muscle) Receives: Procedure: Onlay Mesh |
| Group II | Active comparator | About 15 patients subjected to ventral hernia of sublay mesh procedure (mesh in the retromuscular space) Receives: Procedure: Onlay Mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative Pain
Assessment of post operative Pain by VAS scale
Measured: 4 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start10 May 2023
- Primary completion5 Jul 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Beloul Ali, Al-Azhar University
- Investigators
- Ahmed M Hassan, Professor, Study chair, General Surgery, Faculty of Medicine, Al Azhar University, Assiut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867029
- Sponsor's protocol ID
- Mohamed Beloul
- Status last verified
- May 2023
- First submitted
- 5 Mar 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Onlay and Sublay Mesh in Treatment of Ventral Hernia
- ClinicalTrials.gov ID
- NCT06867029
- Acronym / sponsor ID
- Mohamed Beloul
- Conditions
- Ventral Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 5 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 10 Mar 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.
Hernia is defined as aprotrusion of viscus or part of viscus usually within a peritonial sac through a defect in the abdominal wall.
Ventral abdomenal hernias include all the hernias occuring through the anterior abdominal wall excluding groin hernias ( incisinal hernia, epigastric hernias, paraumbilical hernias, umbilical and lumbar hernias)
Detailed description
Ventral hernia can be categorized according to their characteristic into reducible, irreducible or incarcerated , strangulated and recurrant ventral hernia.
The cause of a primary ventral hernia ia s far from completely understood, but it is undoubtedly multifactorial. familial prediposing play a role with increasing evidance of connective tissue disorders, they are considered as a leading cause of abdominal surgery and account for 2-10% of all abdomenal wall hernias .
Clinical data show that 52% of incisional hernias occur within 6 months postoperative as a result of excessive tension and inadeqate healing of aprevious incision.
The history of prothetic repair in abdominal wall hernias began in 1844 within the use of silver wire coils placed in the floor of groin to induce an inflammatory fibrosis . meny prosthetic material have been tried in hernia repair, but the two most common in current use are polypropylene mesh and expanded polytetrafluoroethylene.
The repair of ventral hernia varies from primary closure, primary closure with an onlay mesh reinforcement, sublay mesh placement, and intraperitonial mesh placement. Primary closure techniques are usually performed for smal fascial defects less than 5 cm in the greaters diameter
An onlay , usually of polyproptlene mesh is sutured to the anterior rectus sheeth after the fascial defect has been closed primary, thes type of repair has the potential advantage of keeping the mesh separeted from the abdomenal content by full abdominal muscle fascial wall thikness.
The sublay (retrorectus) placement of mesh, became popular in 1990, the recurence rates with this repair have been stated to be less than 10%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Procedure: Onlay MeshAbout 15 patients subjected to ventral hernia of onlay mesh procedure (mesh on external oblique muscle) |
| Group II | Active comparator | Procedure: Onlay MeshAbout 15 patients subjected to ventral hernia of sublay mesh procedure (mesh in the retromuscular space) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Ventral Hernia patients
Key exclusion criteria (3 listed)
- Age below 18 years.
- Complicated hernia.
- Uncompensated heart or lung diseases, haemorrhagic disorders
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 MeshAlso: Sublay Meshto compare between two techniques of mesh placement in uncomplicated ventral hernias, onlay (mesh on external oblique) versus sublay (mesh in the retromuscular space). | Procedure or surgery | Group I, Group II |
Primary outcome
Post operative Pain
Time frame: 4 hours post operative
Assessment of post operative Pain by VAS scale
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 Mar 2025.
- 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.
Ahmed M Hassan, Professor study chair
General Surgery, Faculty of Medicine, Al Azhar University, Assiut
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 in people with Ventral Hernia, run by Al-Azhar 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 10 Mar 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?
Post operative Pain (time frame: 4 hours post operative). 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 Mar 2025.