Clinical trial NCT06643234: Sublay Versus Intraperitoneal Onlay Mesh Repair in Large Ventral Hernias
Official title: Sublay Versus Intraperitoneal Onlay Mesh Repair in Large Ventral Hernias. A New Technique
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ventral Hernia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized controlled study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: -Recurrence rate one year post operative.
timeFrame: 1 year postoperative
Secondary outcomes:
measure: 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).
timeFrame: 1 year postoperative
Other outcomes:
Locations:
Study officials:
References:
citation: 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.