NCT06867029

Brief Summary

Hernia is defined as aprotrusion of viscus or part of viscus usually within a peritonial sac through a defect in the abdominal wall. Ventral abdomenal hernias include all the hernias occuring through the anterior abdominal wall excluding groin hernias ( incisinal hernia, epigastric hernias, paraumbilical hernias, umbilical and lumbar hernias)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
Last Updated

March 10, 2025

Status Verified

May 1, 2023

Enrollment Period

1.2 years

First QC Date

March 5, 2025

Last Update Submit

March 5, 2025

Conditions

Ventral Hernia

Outcome Measures

Primary Outcomes (1)

  • Post operative Pain

    Assessment of post operative Pain by VAS scale

    4 hours post operative

Study Arms (2)

Group I

ACTIVE COMPARATOR

About 15 patients subjected to ventral hernia of onlay mesh procedure (mesh on external oblique muscle)

Procedure: Onlay Mesh

Group II

ACTIVE COMPARATOR

About 15 patients subjected to ventral hernia of sublay mesh procedure (mesh in the retromuscular space)

Procedure: Onlay Mesh

Interventions

Onlay MeshPROCEDURE

to compare between two techniques of mesh placement in uncomplicated ventral hernias, onlay (mesh on external oblique) versus sublay (mesh in the retromuscular space).

Also known as: Sublay Mesh
Group IGroup II

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Ventral Hernia patients

You may not qualify if:

  • Age below 18 years.
  • Complicated hernia.
  • Uncompensated heart or lung diseases, haemorrhagic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar University Hospitals

Asyut, Egypt

Location

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Ahmed M Hassan, Professor

    General Surgery, Faculty of Medicine, Al Azhar University, Assiut

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of General Surgery

Study Record Dates

First Submitted

March 5, 2025

First Posted

March 10, 2025

Study Start

May 10, 2023

Primary Completion

July 5, 2024

Study Completion

July 10, 2024

Last Updated

March 10, 2025

Record last verified: 2023-05

Locations

EG(1)