OutcomesNCT07908758
Short Term Outcomes of for Primary Small Sized Midline Ventral Hernia
A study testing Group I:Extended Totally Extraperitoneal Retro-muscular Repair in people with Outcomes and Extraperitoneal, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to assess the short-term outcomes of endoscopic extended totally extraperitoneal repair in primary small-sized ventral hernias, with specific regard to surgical site occurrences and hernia recurrence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Outcomes, Extraperitoneal, Ventral Hernia
- What is being tested?
- Group I:Extended Totally Extraperitoneal Retro-muscular Repair
- 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
- 30 Aug 2024to 30 Jul 2025
- 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
- All patients ≥18 years of age presenting with uncomplicated primary or recurrent ventral hernia with an abdominal wall defect less than 4 cm
Who cannot join
- Age <18 years
- complicated ventral hernia
- large ventral hernia (defect >5 cm)
- absolute contraindications for general anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short Term Outcomes of Endoscopic Extended Totally Extraperitoneal Repair for Primary Small Sized Midline Ventral Hernia
The aim of this study is to assess the short-term outcomes of endoscopic extended totally extraperitoneal repair in primary small-sized ventral hernias, with specific regard to surgical site occurrences and hernia recurrence.
Read the detailed description
Ventral hernia repair is one of the most common surgical procedures in general surgical practice, yet the optimal treatment for ventral hernias remains debatable. Open surgical methods were the sole available techniques for ventral hernia repair until 1993.
Although the exact incidence of recurrence is unknown, it is estimated that 30-50% of patients developed recurrent hernias following primary suture repair, which decreased significantly to 1-14% with the introduction of prosthetic meshes.
Laparoscopic ventral hernia repair was first introduced in 1993 by Le Blanc and Booth, who reported the initial case managed by intraperitoneal onlay mesh , demonstrating early recovery and reduced surgical wound complications. However, adhesive bowel obstruction, mesh erosion, and enterocutaneous fistula arising from direct contact of the mesh with the viscera remained notable disadvantages of intraperitoneal onlay mesh.
espite varying approaches, debate continues between open and minimally invasive techniques regarding the optimal placement of the mesh. Current evidence-based trends suggest four general principles have emerged in contemporary ventral hernia management: mesh reinforcement, retromuscular mesh placement, primary fascial closure, and minimally invasive techniques.
The aim of this study is to assess the short-term outcomes of endoscopic extended totally extraperitoneal repair in primary small-sized ventral hernias, with specific regard to surgical site occurrences and hernia recurrence.
- Conditions
- Outcomes, Extraperitoneal, Ventral Hernia, Midline
- Being tested
- Group I:Extended Totally Extraperitoneal Retro-muscular Repair
- Keywords
- Midline, Ventral Hernia, Outcomes, Extended Totally Extraperitoneal, Endoscopic
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group I:Extended Totally Extraperitoneal Retro-muscular RepairProcedure or surgery
30 patients diagnosed with uncomplicated ventral hernias who are admitted to the GIT and Laparoscopic Surgery
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Extended Totally Extraperitoneal Retro-muscular Repair | Experimental | 30 patients diagnosed with uncomplicated ventral hernias who are admitted to the GIT and Laparoscopic Surgery Unit Receives: Procedure: Group I:Extended Totally Extraperitoneal Retro-muscular Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Morbidity (Surgical Field Occurrence/Surgical Site Occurrence)
Measured: scheduled at 1 week, 1 month, 3 months, 6 months, and 12 months.
Secondary outcomes (1)
Hernia recurrence
Measured: scheduled at 1 week, 1 month, 3 months, 6 months, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start30 Aug 2024
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OutcomesStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Moussa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908758
- Sponsor's protocol ID
- 36264MS681/8/24
- Status last verified
- Aug 2024
- First submitted
- 24 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It will be available if it needed
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Outcomes of Endoscopic Extended Totally Extraperitoneal Repair for Primary Small Sized Midline Ventral Hernia
- ClinicalTrials.gov ID
- NCT07908758
- Acronym / sponsor ID
- 36264MS681/8/24
- Conditions
- Outcomes, Extraperitoneal, Ventral Hernia, Midline
- Keywords
- Midline, Ventral Hernia, Outcomes, Extended Totally Extraperitoneal, Endoscopic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 2 Nov 2026 (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.
The aim of this study is to assess the short-term outcomes of endoscopic extended totally extraperitoneal repair in primary small-sized ventral hernias, with specific regard to surgical site occurrences and hernia recurrence.
Detailed description
Ventral hernia repair is one of the most common surgical procedures in general surgical practice, yet the optimal treatment for ventral hernias remains debatable. Open surgical methods were the sole available techniques for ventral hernia repair until 1993.
Although the exact incidence of recurrence is unknown, it is estimated that 30-50% of patients developed recurrent hernias following primary suture repair, which decreased significantly to 1-14% with the introduction of prosthetic meshes.
Laparoscopic ventral hernia repair was first introduced in 1993 by Le Blanc and Booth, who reported the initial case managed by intraperitoneal onlay mesh , demonstrating early recovery and reduced surgical wound complications. However, adhesive bowel obstruction, mesh erosion, and enterocutaneous fistula arising from direct contact of the mesh with the viscera remained notable disadvantages of intraperitoneal onlay mesh.
espite varying approaches, debate continues between open and minimally invasive techniques regarding the optimal placement of the mesh. Current evidence-based trends suggest four general principles have emerged in contemporary ventral hernia management: mesh reinforcement, retromuscular mesh placement, primary fascial closure, and minimally invasive techniques.
The aim of this study is to assess the short-term outcomes of endoscopic extended totally extraperitoneal repair in primary small-sized ventral hernias, with specific regard to surgical site occurrences and hernia recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1: Extended Totally Extraperitoneal Retro-muscular Repair | Experimental | Procedure: Group I:Extended Totally Extraperitoneal Retro-muscular Repair30 patients diagnosed with uncomplicated ventral hernias who are admitted to the GIT and Laparoscopic Surgery Unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients ≥18 years of age presenting with uncomplicated primary or recurrent ventral hernia with an abdominal wall defect less than 4 cm
Key exclusion criteria (4 listed)
- Age <18 years
- complicated ventral hernia
- large ventral hernia (defect >5 cm)
- absolute contraindications for general anesthesia
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 |
|---|---|---|
| Group I:Extended Totally Extraperitoneal Retro-muscular Repair30 patients diagnosed with uncomplicated ventral hernias who are admitted to the GIT and Laparoscopic Surgery | Procedure or surgery | Group 1: Extended Totally Extraperitoneal Retro-muscular Repair |
Primary outcome
Incidence of Morbidity (Surgical Field Occurrence/Surgical Site Occurrence)
Time frame: scheduled at 1 week, 1 month, 3 months, 6 months, and 12 months.
1 secondary outcome
Hernia recurrence
Time frame: scheduled at 1 week, 1 month, 3 months, 6 months, and 12 months.
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 2 Nov 2026.
- Individual participant dataSharing planned: Yes. It will be available if it needed
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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 Group I:Extended Totally Extraperitoneal Retro-muscular Repair in people with Outcomes and Extraperitoneal, run by Tanta 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 4 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 2 Nov 2026. 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?
Incidence of Morbidity (Surgical Field Occurrence/Surgical Site Occurrence) (time frame: scheduled at 1 week, 1 month, 3 months, 6 months, and 12 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 2 Nov 2026.