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Not yet recruiting NCT06643234

Sublay Versus Intraperitoneal Onlay Mesh Repair in Large Ventral Hernias

No phase Interventional Ventral Hernia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ventral hernia repair.
Who it may be relevant to
Registry conditions: Ventral Hernia. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Procedure Ventral hernia repair
    Comparative between both techniques

Primary outcome measures

  • -Recurrence rate one year post operative. [Time frame: 1 year postoperative]
Secondary outcome measures (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). [Time frame: 1 year postoperative]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 30604264

Identifiers

NCT: NCT06643234 · Large abdominal hernia

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗