Sublay Versus Intraperitoneal Onlay Mesh Repair in Large Ventral Hernias

NCT06643234 | Not Yet Recruiting

• 1 other identifier: Large abdominal hernia
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ventral Hernia

Outcome Measures

Primary Outcomes (1)

• -Recurrence rate one year post operative.

  Number of recurrent cases

  1 year postoperative

Secondary Outcomes (1)

• 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

Study Arms (2)

Group (A) modified sublay hernioplasty:

ACTIVE COMPARATOR

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

Group (B) IPOM:

ACTIVE COMPARATOR

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

Interventions

Ventral hernia repair PROCEDURE

Comparative between both techniques

Group (A) modified sublay hernioplasty:; Group (B) IPOM:

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ahmed Kahlawy Mahrous Mohamed: lead

Related Publications (1)

• 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.

  PMID: 30604264 BACKGROUND

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ahmed K Mahrous, Resident doctor

CONTACT

01064620839; Ahmed.16311091@med.any.edu.eg

Ahmed M Abdallah, Doctor

CONTACT

+20 101 8942253

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: Prospective randomized controlled study

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 16, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 26, 2024

Record last verified: 2024-10