- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06867029
Onlay and Sublay Mesh in Treatment of Ventral Hernia
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)
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Assiut, Egypt
- Al-Azhar University Hospitals
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Ventral Hernia patients
Exclusion Criteria:
- Age below 18 years.
- Complicated hernia.
- Uncompensated heart or lung diseases, haemorrhagic disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Group I
About 15 patients subjected to ventral hernia of onlay mesh procedure (mesh on external oblique muscle)
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to compare between two techniques of mesh placement in uncomplicated ventral hernias, onlay (mesh on external oblique) versus sublay (mesh in the retromuscular space).
Other Names:
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Active Comparator: Group II
About 15 patients subjected to ventral hernia of sublay mesh procedure (mesh in the retromuscular space)
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to compare between two techniques of mesh placement in uncomplicated ventral hernias, onlay (mesh on external oblique) versus sublay (mesh in the retromuscular space).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Post operative Pain
Time Frame: 4 hours post operative
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Assessment of post operative Pain by VAS scale
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4 hours post operative
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ahmed M Hassan, Professor, General Surgery, Faculty of Medicine, Al Azhar University, Assiut
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mohamed Beloul
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ventral Hernia
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Varazdin General HospitalCompletedIncisional Ventral Hernia | Recurrent Ventral HerniaCroatia
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Anne Arundel Health System Research InstituteMedtronic - MITGCompletedGrade I Ventral Hernia | Grade II Ventral HerniaUnited States
-
Sofregen Medical, Inc.TerminatedVentral Hernia RepairUnited States
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University Hospital, Strasbourg, FranceRecruitingVentral Hernia RepairFrance
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Makassed General HospitalSuspended
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GSVM Medical CollegeCompleted
-
Zaza DemetrashviliRecruitingLarge Midline Ventral HerniaGeorgia
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Hvidovre University HospitalUniversity of CopenhagenCompleted
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Hvidovre University HospitalCopenhagen University Hospital at HerlevCompleted
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Distalmotion SAConfinisCompletedVentral Hernia RepairSwitzerland, Austria, France, Germany
Clinical Trials on Onlay Mesh
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University Hospital, Gentofte, CopenhagenZealand University Hospital; Aarhus University Hospital; Hvidovre University... and other collaboratorsTerminated
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Sana Ehsan ullahCompletedVentral Hernia | Incisional HerniaPakistan
-
Services Hospital, LahoreCompletedParaumbilical HerniaPakistan
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Bakirkoy Dr. Sadi Konuk Research and Training HospitalNot yet recruitingOnlay Mesh | Umbilical Hernia RepairTurkey (Türkiye)
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Karolinska InstitutetCompletedUmbilical HerniaSweden
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Austrian Hernia Study GroupTerminatedObesity | Incisional HerniaAustria
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Konya Meram State HospitalCompleted
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University of Campania "Luigi Vanvitelli"CompletedIncisional Hernia
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Hayat Abad Medical Complex, PeshawarCompletedHernia | Abdominal Wall Hernia | Ventral Hernia Repair | Synthetic Mesh | Incisional Hernia RepairPakistan
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University Hospital, Basel, SwitzerlandClinical Trial Unit, University Hospital Basel, SwitzerlandTerminatedUmbilical HerniaSwitzerland, Germany