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

Comparative Study of Modified Guarnieri-Desarda Technique Versus Lichtenstein Technique in Inguinal Hernia Repair

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.

Study Overview

• Status: Recruiting
• Conditions: Inguinal Hernia
• Intervention / Treatment: Procedure: Lichtenstein Mesh-Based Hernioplasty; Procedure: Combined Modified Guarnieri-Desarda Tissue-Based Hernioplasty

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fadi F. Khalil, MSc; Phone Number: +2 01285612963; Email: fady.azmi37080@postgrad.kasralainy.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Kasralainy
    • Contact: Fadi Khalil, MSc; Phone Number: +2 01285612963; Email: fady.azmi37080@postgrad.kasralainy.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Postoperative Complications	The occurrence of postoperative complications such as seroma, hematoma, wound infection, and testicular complications (e.g., hydrocele, cord induration) will be recorded and analyzed for each group.	At 2 weeks, 1 month, and 3 months post-surgery.
Hernia Recurrence Rate	The rate of hernia recurrence will be assessed through clinical examination and imaging, comparing recurrence between the Lichtenstein mesh-based repair group and the modified Guarnieri-Desarda tissue-based repair group.	At 6 months and 1 year post-surgery.
Testicular Vascularity	Testicular vascularity will be evaluated using testicular duplex and ultrasound, comparing any changes pre- and post-surgery between the two groups.	At 3 months post-surgery.

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Fadi F. Khalil, MSc, Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: September 10, 2024
• First Submitted That Met QC Criteria: September 12, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Inguinal Hernia; Hernia Repair; Guarnieri Technique; Desarda Technique; Lichtenstein Hernioplasty
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: MD-255-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) including demographic information, surgical outcomes, and follow-up data (postoperative pain scores, complications, testicular vascularity and size, and hernia recurrence rates) will be made available. Data will be shared with researchers upon reasonable request for the purpose of secondary analysis. Access to the data will be granted following the publication of the study results and will be available for up to 5 years after study completion. Participants' confidentiality will be protected, and any shared data will be anonymized.
• IPD Sharing Time Frame: Data will be available for a period of 5 years after the study is completed.

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No