Sublay Versus Intraperitoneal Onlay Mesh Repair in Large Ventral Hernias

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ventral Hernia
• Intervention / Treatment: Procedure: Ventral hernia repair

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed K Mahrous, Resident doctor; Phone Number: 01064620839; Email: Ahmed.16311091@med.any.edu.eg
• Study Contact Backup: Name: Ahmed M Abdallah, Doctor; Phone Number: +20 101 8942253

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group (A) modified sublay hernioplasty: In the classic sublay hernioplasty technique, the hernia sac remains unopened. The procedure involves dissection of the posterior rectus sheath, which is then sutured at the midline. A mesh is placed behind the rectus muscle and in front of the posterior rectus sheath. Subsequently, the rectus muscle and anterior rectus sheath are sutured together at the midline, introducing tension to the repair. Conversely, the modified sublay hernioplasty technique follows a similar approach but with a key difference: the rectus muscle and anterior rectus sheath are left undisturbed without suturing them together. This modification aims to achieve a tension free repair, potentially reducing complications and enhancing overall outcomes.	Procedure: Ventral hernia repair; Comparative between both techniques
Active Comparator: Group (B) IPOM: The hernia repair procedure involved several key steps. First, the hernial sac was fully exposed and completely removed. Following this, a synthetic mesh was placed internally, covering the defect with overlapping edges to ensure adequate reinforcement. The mesh was then fixed to the anterior abdominal wall using sutures, which were applied through the supporting layers of the abdominal wall to secure the mesh in place. Preoperatively, all patients underwent comprehensive general and local examinations, routine laboratory blood tests, and abdominal ultrasound to evaluate the size of the hernia defect.	Procedure: Ventral hernia repair; Comparative between both techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
-Recurrence rate one year post operative.	Number of recurrent cases	1 year postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	The number of cases come with post operative infection , pain(according to pain rating scale) , postoperative days of stay and intraoperative complications.	1 year postoperative

Collaborators and Investigators

• Sponsor: Ahmed Kahlawy Mahrous Mohamed

Publications and helpful links

General Publications

• Kockerling F, Simon T, Adolf D, Kockerling D, Mayer F, Reinpold W, Weyhe D, Bittner R. Laparoscopic IPOM versus open sublay technique for elective incisional hernia repair: a registry-based, propensity score-matched comparison of 9907 patients. Surg Endosc. 2019 Oct;33(10):3361-3369. doi: 10.1007/s00464-018-06629-2. Epub 2019 Jan 2.

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 29, 2024
• First Submitted That Met QC Criteria: October 12, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): October 26, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: Large abdominal hernia

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No