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Not yet recruitingNCT06643234Updated Oct 26, 2024

Sublay Versus Intraperitoneal Onlay Mesh Repair in Large Ventral Hernias

An interventional study of Ventral hernia repair in Ventral Hernia, sponsored by Ahmed Kahlawy Mahrous Mohamed. Not yet recruiting. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-26.

Sponsored by Ahmed Kahlawy Mahrous Mohamed · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Ventral Hernia
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    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.

    Procedure: Ventral hernia repair

  • Active comparator
    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.

    Procedure: Ventral hernia repair

Interventions

  • ProcedureVentral hernia repair

    Comparative between both techniques

05

What researchers measure

Primary outcomes

  1. -Recurrence rate one year post operative.

    Number of recurrent cases

    Time frame: 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).

    The number of cases come with post operative infection , pain(according to pain rating scale) , postoperative days of stay and intraoperative complications.

    Time frame: 1 year postoperative

06

Study locations

No study locations are listed for this record.

07

References and documents

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. PubMed 30604264 ↗
08

Registry details

Key details

Study ID
NCT06643234
Lead sponsor
Ahmed Kahlawy Mahrous Mohamed
Responsible party
Ahmed Kahlawy Mahrous Mohamed (Principal investigator, Assiut University) — Sponsor-investigator
First posted
Oct 16, 2024
Start date
Nov 1, 2024 (estimated)
Primary completion
Oct 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Oct 26, 2024

Study contacts

Ahmed K Mahrous, Resident doctor
Contact
Ahmed.16311091@med.any.edu.eg
01064620839
Ahmed M Abdallah, Doctor
Contact
+20 101 8942253

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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