Sublay Versus Intraperitoneal Onlay Mesh Repair in Large Ventral Hernias

Not Applicable

Not yet recruiting

• Conditions: Ventral Hernia

• Registration Number: NCT06643234
• Lead Sponsor: Ahmed Kahlawy Mahrous Mohamed

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.

Study Timeline

• Study First Submitted: 2024-09-29
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-12
• Study First Posted: 2024-10-16
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-26
• Study Start: 2024-11-01
• Primary Completion: 2026-10-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
-Recurrence rate one year post operative.	1 year postoperative	Number of recurrent cases

Secondary Outcome Measures

Name	Time	Method
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 postoperative	The number of cases come with post operative infection , pain(according to pain rating scale) , postoperative days of stay and intraoperative complications.