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

NCT06595628 | Recruiting

• 1 other identifier: MD-255-2022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inguinal Hernia

Keywords

Inguinal Hernia; Hernia Repair; Guarnieri Technique; Desarda Technique; Lichtenstein Hernioplasty

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Assessment

  Postoperative pain will be evaluated using the Mankoski Pain Scale (0-10). Pain scores will be recorded at different time intervals to assess immediate and long-term postoperative pain, with scores from 0 to 2 considered negligible, and scores from 3 to 10 considered significant.

  At 2 weeks, 1 month, 3 months, and 6 months post-surgery.

Secondary Outcomes (3)

• Incidence of Postoperative Complications

  At 2 weeks, 1 month, and 3 months post-surgery.

• Hernia Recurrence Rate

  At 6 months and 1 year post-surgery.

• Testicular Vascularity

  At 3 months post-surgery.

Study Arms (2)

Lichtenstein Mesh-Based Repair

ACTIVE COMPARATOR

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.

Procedure: Lichtenstein Mesh-Based Hernioplasty

Combined Modified Guarnieri-Desarda Tissue-Based Repair

EXPERIMENTAL

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.

Procedure: Combined Modified Guarnieri-Desarda Tissue-Based Hernioplasty

Interventions

Lichtenstein Mesh-Based Hernioplasty 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.

Lichtenstein Mesh-Based Repair

Combined Modified Guarnieri-Desarda Tissue-Based Hernioplasty 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.

Combined Modified Guarnieri-Desarda Tissue-Based Repair

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only individuals who self-identify as male are eligible to participate.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasralainy

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Fadi F. Khalil, MSc

  Kasr El Aini Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fadi F. Khalil, MSc

CONTACT

01285612963; fady.azmi37080@postgrad.kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Residend of Surgery

Model Details: 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.

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: October 10, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available for a period of 5 years after the study is completed.
• Access Criteria: Who: Qualified researchers with a scientifically sound proposal will be able to access the individual participant data (IPD) and supporting information. What: Researchers will be able to access de-identified IPD, including demographic data, surgical outcomes, follow-up data (e.g., pain scores, complications, testicular vascularity, and hernia recurrence), and supporting documents such as the study protocol, statistical analysis plan, and informed consent form. How: Researchers must submit a formal request to the corresponding author detailing their research proposal, the objectives of the secondary analysis, and how the data will be used. Requests will be evaluated by the study investigators. If approved, data will be shared via a secure, password-protected data-sharing platform, ensuring compliance with data protection regulations.

Locations

EG (1)