Sublay Versus Intraperitoneal Onlay Mesh Repair in Large Ventral Hernias

NCT ID: NCT06643234

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2026-12-01

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.

Conditions

Ventral Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Ventral hernia repair

Intervention Type: PROCEDURE

Comparative between both techniques

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.

Group Type: ACTIVE_COMPARATOR

Ventral hernia repair

Intervention Type: PROCEDURE

Comparative between both techniques

Interventions

Ventral hernia repair

Comparative between both techniques

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ahmed Kahlawy Mahrous Mohamed

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Kahlawy Mahrous Mohamed

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Ahmed K Mahrous, Resident doctor

Role: CONTACT

Ahmed.16311091@med.any.edu.eg

01064620839

Ahmed M Abdallah, Doctor

Role: CONTACT

+20 101 8942253

References

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.

Reference Type: BACKGROUND

PMID: 30604264 (View on PubMed)

Other Identifiers

Large abdominal hernia

Identifier Type: -

Identifier Source: org_study_id