NCT07386067

Brief Summary

Inguinal hernia repair is the most common operation performed by general surgeons worldwide, surgical repair is the only established definitive treatment for inguinal hernia with multiple variable described approaches, Since Lichtenstein and his colleagues pronounced the use of mesh in tension-free inguinal hernia repair, the open Lichtenstein mesh repair of inguinal hernia became a standard of care for inguinal hernia repair due to easiness of performance with low recurrence rates (1, 2, 3). In the past many different factors have been identified to reduce chronic postoperative inguinal pain CPIP, Sophisticated studies suggested that mechanical mesh fixation should be avoided, and proper knowledge of inguinal nerves is essential (4-9). Surgeons must consider patient characteristics and mesh properties when selecting a mesh for hernia treatment. Mechanical compatibility between meshes and abdominal wall layers is crucial for avoiding complications. Lightweight, monofilament meshes with large pores and minimal surface area are ideal; however, the surgeon should never forget that the way the mesh is positioned as important as the type of mesh used. Despite the new materials available, surgical skill still has a major role in preventing hernia post-operative complications and recurrence. Future research will continue to focus on the surgical techniques and biomaterials to achieve the best outcomes (10). Our method uses a smaller single mesh that covers all weaknesses in the inguinal canal and is covered with a fibro-cremasteric sheath to prevent the prosthesis from coming into touch with neural processes. This method is applicable to all cases of primary inguinal hernia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

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

January 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 27, 2026

Last Update Submit

January 27, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • hernia recurrence

    The rate of return of the hernia in the same location.

    6 months following the operation

Study Arms (1)

hernia arm represent patients with inguinal hernia

EXPERIMENTAL

the new mesh desined to fit the posterior wall of inguinal canal

Procedure: new mesh design for inguinal hernia

Interventions

the new mesh design is cut to fit the posterior wall of the inguinal canal

hernia arm represent patients with inguinal hernia

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • males older than 18 years old with primary inguinal hernia.

You may not qualify if:

  • females patients with bleeding tendency.
  • Complicated inguinal hernia.
  • Huge inguinoscrotal hernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig Univeesity Hospitals

Zagazig, 44519, Egypt

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant professor

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 4, 2026

Study Start

January 1, 2025

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

February 4, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations