Ventral HerniaNCT06149858
Ventral Mesh Hernioplasty : Laparoscopic Versus Open Sublay
A study testing hernioplasty in people with Ventral Hernia, run by Assiut University.
Trial summary
To compare between laparoscopic ventral hernia repair and open sublay technique (recurrence ,operative time ,bleeding ,rate of complication and injury , seroma, post operative pain) Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- hernioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Mar 2026
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All cases of midline ventral hernia fit for surgery
Who cannot join
- Surgically unfit cases
- Complicated hernia (obstructed ,irreducible, strangulated)
- incisional ,massive ,recurrent hernias
Trial locations and contacts
No sites are listed yet.
About this study
To compare between laparoscopic ventral hernia repair and open sublay technique (recurrence ,operative time ,bleeding ,rate of complication and injury , seroma, post operative pain)
Read the detailed description
A hernia usually happens in abdomen or groin, when one of your organs pushes through the muscle or tissue that contains it. Most hernias eventually will need surgical repair.
sublay mesh repair has the lowest recurrence and surgical site infection in open anterior abdominal hernia repair it is a perfect choice for the repair of ventral abdominal hernia the principles included two main steps: (1) mesh placement deep into the recti muscles and (2) mesh extension beyond the hernia defect.
Laparoscopic ventral hernia repair (LVHR) has established itself as a well-accepted option in the treatment of hernias. Clear benefits have been established regarding the superiority of LVHR in terms of fewer wound infections compared with open repairs. Meticulous technique and appropriate patient selection are critical to obtain the reported results.
- In the laparoscopic technique, a prosthetic mesh is inserted through a trocar into the abdominal cavity and fixed against the abdominal wall. After reducing the hernia contents, the hernia sac is left unresected, and most surgeons do not place additional sutures for closing the hernia orifice. A specific risk of laparoscopic hernia repair lies in freeing adhesions between intestine and abdominal wall, which may result in (sometimes unrecognised) bowel perforation . The mesh should overlap the hernia orifice by at least 5 cm and is anchored to the abdominal wall with tacks, transfascial sutures, or a combination of the two methods. In laparoscopic abdominal hernia repair, mesh placement methods are generally classified into intraperitoneal onlay mesh (IPOM), transabdominal abdominal preperitoneal (TAPP)
- Conditions
- Ventral Hernia
- Being tested
- hernioplasty
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hernioplastyProcedure or surgery
ventral hernia repair with mesh
| Study group | Role | What they receive |
|---|---|---|
| sublay | Experimental | patients with ventral hernia operated as sublay mesh repair positioning of mesh under sheath Receives: Procedure: hernioplasty |
| laparoscopic | Experimental | patients with ventral hernia operated as laparoscopic repair positioning TAPP mesh Receives: Procedure: hernioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence rate
compare between laparoscopic ventral hernia repair and open sublay technique in how long the hernia take to occur again
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
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 Ventral HerniaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed hussein abozeid ahmed, Assiut University
- Investigators
- hisham ryad, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149858
- Sponsor's protocol ID
- ventral hernia repair
- Status last verified
- Nov 2023
- First submitted
- 10 Nov 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Issa M, Noureldin K, Elgadi A, Abdelaziz A, Badawi M, Makram M. Evaluation of the Sublay Mesh Repair Outcomes in Different Types of Ventral Hernia. Cureus. 2021 Dec 21;13(12):e20590. doi: 10.7759/cureus.20590. eCollection 2021 Dec.
PubMed 35103166
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventral Mesh Hernioplasty : Laparoscopic Versus Open Sublay
- ClinicalTrials.gov ID
- NCT06149858
- Acronym / sponsor ID
- ventral hernia repair
- Conditions
- Ventral Hernia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 29 Nov 2023 (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.
To compare between laparoscopic ventral hernia repair and open sublay technique (recurrence ,operative time ,bleeding ,rate of complication and injury , seroma, post operative pain)
Detailed description
A hernia usually happens in abdomen or groin, when one of your organs pushes through the muscle or tissue that contains it. Most hernias eventually will need surgical repair.
sublay mesh repair has the lowest recurrence and surgical site infection in open anterior abdominal hernia repair it is a perfect choice for the repair of ventral abdominal hernia the principles included two main steps: (1) mesh placement deep into the recti muscles and (2) mesh extension beyond the hernia defect.
Laparoscopic ventral hernia repair (LVHR) has established itself as a well-accepted option in the treatment of hernias. Clear benefits have been established regarding the superiority of LVHR in terms of fewer wound infections compared with open repairs. Meticulous technique and appropriate patient selection are critical to obtain the reported results.
- In the laparoscopic technique, a prosthetic mesh is inserted through a trocar into the abdominal cavity and fixed against the abdominal wall. After reducing the hernia contents, the hernia sac is left unresected, and most surgeons do not place additional sutures for closing the hernia orifice. A specific risk of laparoscopic hernia repair lies in freeing adhesions between intestine and abdominal wall, which may result in (sometimes unrecognised) bowel perforation . The mesh should overlap the hernia orifice by at least 5 cm and is anchored to the abdominal wall with tacks, transfascial sutures, or a combination of the two methods. In laparoscopic abdominal hernia repair, mesh placement methods are generally classified into intraperitoneal onlay mesh (IPOM), transabdominal abdominal preperitoneal (TAPP)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sublay | Experimental | Procedure: hernioplastypatients with ventral hernia operated as sublay mesh repair positioning of mesh under sheath |
| laparoscopic | Experimental | Procedure: hernioplastypatients with ventral hernia operated as laparoscopic repair positioning TAPP mesh |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All cases of midline ventral hernia fit for surgery
Key exclusion criteria (3 listed)
- Surgically unfit cases
- Complicated hernia (obstructed ,irreducible, strangulated)
- incisional ,massive ,recurrent hernias
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 |
|---|---|---|
| hernioplastyventral hernia repair with mesh | Procedure or surgery | laparoscopic, sublay |
Primary outcome
recurrence rate
Time frame: baseline
compare between laparoscopic ventral hernia repair and open sublay technique in how long the hernia take to occur again
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Background: PubMed 35103166Issa M, Noureldin K, Elgadi A, Abdelaziz A, Badawi M, Makram M. Evaluation of the Sublay Mesh Repair Outcomes in Different Types of Ventral Hernia. Cureus. 2021 Dec 21;13(12):e20590. doi: 10.7759/cureus.20590. eCollection 2021 Dec.
- Individual participant dataSharing planned: No
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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.
hisham ryad study director
Questions about this trial
What is this clinical trial studying?
A study testing hernioplasty in people with Ventral Hernia, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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 ahmed hussein (01091081032, ahmed.nazeir.1996@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence rate (time frame: baseline). 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 NCT06149858, 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 Nov 2023; AzTrials last refreshed its copy on 31 Oct 2026.