Ventral HerniaNCT06209450
Sutured vs Sutureless Mesh Fixation for Onlay Ventral Hernia Repair
A study testing Ventral hernia repair with mesh fixation in people with Ventral Hernia, run by Assiut University.
Trial summary
Comparison beta sutured and suturless mesh fixation for ventral hernia regarding recurrence rates and complications rate Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- Ventral hernia repair with mesh fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Mar 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ventral hernia
- both sexes
Who cannot join
- obstructed or complicated ventral hernia
- incisional hernia
- recurrent hernia
- multiple ventral hernia
- large hernia more than 5 cm
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Sutured vs Suturless Mesh Fixation for Onlay Ventral Hernia Repair
Comparison beta sutured and suturless mesh fixation for ventral hernia regarding recurrence rates and complications rate
Read the detailed description
Ventral hernia repair is common procedure with over 250000 repairs each year in the unites states . Most ventral hernias are repaired using tension free type of repair using mesh that bridge the defect and reinforce the abdominal wall .
The mesh fixation technique has impact on recurrence rates,chronic pain and complications rates . Suturless ventral hernia repair with sealing agent fixation proved to be durable with comperable complication profile to other techniques.
- Conditions
- Ventral Hernia
- Being tested
- Ventral hernia repair with mesh fixation
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventral hernia repair with mesh fixationProcedure or surgery
Sutured versus suturless mesh fixation
| Study group | Role | What they receive |
|---|---|---|
| Ventral hernia repair | Experimental | Not described Receives: Procedure: Ventral hernia repair with mesh fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Intraoperative and post operative complications occur due to technique used in study
Measured: One year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Mohammed Mahmoud Gadelhak, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209450
- Sponsor's protocol ID
- Hernia
- Status last verified
- Jan 2024
- First submitted
- 5 Jan 2024
- Last updated
- 17 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sutured vs Suturless Mesh Fixation for Onlay Ventral Hernia Repair
- ClinicalTrials.gov ID
- NCT06209450
- Acronym / sponsor ID
- Hernia
- Conditions
- Ventral Hernia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 17 Jan 2024 (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.
Comparison beta sutured and suturless mesh fixation for ventral hernia regarding recurrence rates and complications rate
Detailed description
Ventral hernia repair is common procedure with over 250000 repairs each year in the unites states . Most ventral hernias are repaired using tension free type of repair using mesh that bridge the defect and reinforce the abdominal wall .
The mesh fixation technique has impact on recurrence rates,chronic pain and complications rates . Suturless ventral hernia repair with sealing agent fixation proved to be durable with comperable complication profile to other techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ventral hernia repair | Experimental | Procedure: Ventral hernia repair with mesh fixation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ventral hernia
- both sexes
Key exclusion criteria (5 listed)
- obstructed or complicated ventral hernia
- incisional hernia
- recurrent hernia
- multiple ventral hernia
- large hernia more than 5 cm
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 |
|---|---|---|
| Ventral hernia repair with mesh fixationSutured versus suturless mesh fixation | Procedure or surgery | Ventral hernia repair |
Primary outcome
Complications
Time frame: One year after surgery
Intraoperative and post operative complications occur due to technique used in study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Ventral hernia repair with mesh fixation 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 2 inclusion and 5 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 Jan 2024. 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 Khaled Muhammad Mahmoud (01069094017, Khaledgad19844@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications (time frame: One year after surgery). 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 Jan 2024.