Modified Guarnieri-Desarda Technique Versus Lichtenstein Technique in Inguinal Hernia Repair

NCT ID: NCT06595628

Last Updated: 2025-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-10

Study Completion Date

2025-10-01

Brief Summary

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The aim of this study is to compare the surgical outcome of both Lichnichtien tension free mesh hernioplasty of inguinal hernia and the combined modified Guarnieri Desarda technique in terms of postoperative pain, post operative complications (seroma, hematoma, wound infection), chronic inguinodenia, early recurrence and assessment of testicular vascularity and size by application of a testicular duplex and ultrasound.

Detailed Description

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Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study follows a parallel assignment model. Patients are randomly assigned to one of two groups: the Lichtenstein mesh-based repair group (L group) or the combined modified Guarnieri-Desarda tissue-based repair group (C group). The interventions are performed independently in each group, with outcomes compared between the two. There is no blinding in this study, and both the participants and the surgeons know which procedure is being performed (open-label study). The primary focus is on comparing the effectiveness and safety of the two surgical techniques.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Lichtenstein Mesh-Based Repair

Participants in this arm will undergo the Lichtenstein tension-free hernioplasty, which involves reinforcing the inguinal canal floor using a synthetic mesh. The mesh is fixed to the inguinal ligament and internal oblique aponeurosis, minimizing tension in the repair and reducing the risk of recurrence.

Group Type ACTIVE_COMPARATOR

Lichtenstein Mesh-Based Hernioplasty

Intervention Type PROCEDURE

This is a tension-free hernioplasty procedure that uses a synthetic mesh to reinforce the inguinal canal floor. The mesh is fixed to the inguinal ligament and internal oblique aponeurosis, creating a barrier to prevent hernia recurrence. It is considered the gold standard for inguinal hernia repair and is widely used for its effectiveness in reducing recurrence rates and postoperative complications.

Combined Modified Guarnieri-Desarda Tissue-Based Repair

Participants in this arm will receive the combined modified Guarnieri-Desarda tissue-based repair. This approach involves reconstructing the inguinal canal without the use of synthetic mesh, using the patient's own tissues to reinforce the canal and reduce tension. The technique combines aspects of both the Guarnieri and Desarda methods, aiming to preserve the natural physiology of the inguinal canal while providing tension-free repair.

Group Type EXPERIMENTAL

Combined Modified Guarnieri-Desarda Tissue-Based Hernioplasty

Intervention Type PROCEDURE

This technique combines elements of the Guarnieri and Desarda tissue-based repairs. It does not involve the use of synthetic mesh, relying instead on the patient's own tissues to reinforce the inguinal canal. The Guarnieri technique reshapes the internal ring to improve the inguinal canal's shutter mechanism, while the Desarda technique reinforces the posterior wall using the external oblique aponeurosis. This approach aims to preserve natural anatomy and minimize complications associated with mesh use.

Interventions

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Lichtenstein Mesh-Based Hernioplasty

This is a tension-free hernioplasty procedure that uses a synthetic mesh to reinforce the inguinal canal floor. The mesh is fixed to the inguinal ligament and internal oblique aponeurosis, creating a barrier to prevent hernia recurrence. It is considered the gold standard for inguinal hernia repair and is widely used for its effectiveness in reducing recurrence rates and postoperative complications.

Intervention Type PROCEDURE

Combined Modified Guarnieri-Desarda Tissue-Based Hernioplasty

This technique combines elements of the Guarnieri and Desarda tissue-based repairs. It does not involve the use of synthetic mesh, relying instead on the patient's own tissues to reinforce the inguinal canal. The Guarnieri technique reshapes the internal ring to improve the inguinal canal's shutter mechanism, while the Desarda technique reinforces the posterior wall using the external oblique aponeurosis. This approach aims to preserve natural anatomy and minimize complications associated with mesh use.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adult male patients aged 18 years or older.
* Patients diagnosed with non-complicated inguinal hernia (both direct and indirect).
* Patients able to provide written informed consent to participate in the study.

Exclusion Criteria

* Patients younger than 18 years old.
* Patients with complicated hernias (e.g., inflamed, obstructed, or strangulated hernias).
* Patients with a recurrent inguinal hernia.
* Patients with weak or thin external oblique aponeurosis (intraoperative findings).
* Patients with a history of prior surgery in the inguinal region.
* Patients who refuse to participate in the study.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Fadi Fawzi Azmi Khalil

Residend of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fadi F. Khalil, MSc

Role: PRINCIPAL_INVESTIGATOR

Kasr El Aini Hospital

Locations

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Kasralainy

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Fadi F. Khalil, MSc

Role: CONTACT

01285612963 ext. +2

Facility Contacts

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Fadi Khalil, MSc

Role: primary

01285612963 ext. +2

Other Identifiers

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MD-255-2022

Identifier Type: -

Identifier Source: org_study_id

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