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NCT Number: NCT06643234

Sublay Versus Intraperitoneal Onlay Mesh Repair in Large Ventral Hernias

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ventral Hernia Repair

Procedure

Comparative between both techniques

Primary outcomes

  1. -Recurrence rate one year post operative.

    Time frame: 1 year postoperative

    Number of recurrent cases

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).

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed K Mahrous, Resident doctor

CONTACT

[email protected]

01064620839

Ahmed M Abdallah, Doctor

CONTACT

+20 101 8942253

Sponsors and collaborators

Lead sponsor

Ahmed Kahlawy Mahrous Mohamed

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 16, 2024
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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