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Sublay Versus Intraperitoneal Onlay Mesh Repair in Large Ventral Hernias

Sublay Versus Intraperitoneal Onlay Mesh Repair in Large Ventral Hernias. A New Technique

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06643234
Enrollment
50
Registered
2024-10-16
Start date
2024-11-01
Completion date
2026-12-01
Last updated
2024-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventral Hernia

Brief summary

The aims of this study is to compare the efficacy of modified sublay hernioplasty versus intraperitoneal onlay mesh repair for large ventral hernias. Specifically, this study will assess the primary outcome of recurrence rate one year post surgery and evaluate secondary outcomes, including intraoperative complications, infection rates, pain levels, and post operative hospital stay durations.

Detailed description

In general surgery, the management of ventral abdominal hernias characterized by the protrusion of tissue through weaknesses in the abdominal wall presents significant challenges, particularly when dealing with large ventral hernias, defined as those ≥10 cm or those under tension if closed primarily. Incisional hernias, a specific subset of ventral hernias, add to the complexity of repair. While the Intraperitoneal Onlay Mesh (IPOM) technique is noted for its reduced surgical and postoperative complications and lower reoperation rates, it also suffers from high costs, limited availability of specialized meshes like dynamesh, and increased intraoperative complications. Alternatively, the modified open sublay technique, which employs a primary retro-muscular fascial repair and uses an affordable polypropylene mesh, offers a promising and cost effective solution with potential for a tension free repair. This thesis aims to evaluate and compare these techniques to identify the most effective approach for large ventral hernia repair, balancing surgical outcomes, and complication rates.

Interventions

PROCEDUREVentral hernia repair

Comparative between both techniques

Sponsors

Ahmed Kahlawy Mahrous Mohamed
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Prospective randomized controlled study

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Age (18-70) years, both sexes. * Fitness for surgery. * Patients with uncomplicated ventral hernia. * Large anterior abdominal wall defect.

Exclusion criteria

* Patients don't fit for general anesthesia due to sever co-morbidity. * Patients with complicated ventral hernia. * Patient refusal of surgical intervention. * History of bleeding disorders. * Pregnancy in female patients

Design outcomes

Primary

MeasureTime frameDescription
-Recurrence rate one year post operative.1 year postoperativeNumber of recurrent cases

Secondary

MeasureTime frameDescription
1-infection rates(number of cases) 2-pain level( according to Visual Analog Score for pain) 3-post operative hospital stay duration(number of days) 4-intra and post operative complications(as iatrogenic injury and adhesions).1 year postoperativeThe number of cases come with post operative infection , pain(according to pain rating scale) , postoperative days of stay and intraoperative complications.

Contacts

Primary ContactAhmed K Mahrous, Resident doctor
Ahmed.16311091@med.any.edu.eg01064620839
Backup ContactAhmed M Abdallah, Doctor
+20 101 8942253

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026