Inguinal HerniaNCT06595628
Modified Guarnieri-Desarda Technique Versus Lichtenstein Technique in Inguinal Hernia Repair
A study testing Lichtenstein Mesh-Based Hernioplasty and Combined Modified Guarnieri-Desarda Tissue-Based Hernioplasty in people with Inguinal Hernia, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Lichtenstein Mesh-Based Hernioplasty and Combined Modified Guarnieri-Desarda Tissue-Based Hernioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2024to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Kasralainy
Cairo
Fadi Khalil, MSc, 01285612963 ext. +2, fady.azmi37080@postgrad.kasralainy.edu.eg
About this study
Official title: 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.
- Conditions
- Inguinal Hernia
- Being tested
- Lichtenstein Mesh-Based Hernioplasty, Combined Modified Guarnieri-Desarda Tissue-Based Hernioplasty
- Keywords
- Inguinal Hernia, Hernia Repair, Guarnieri Technique, Desarda Technique, Lichtenstein Hernioplasty
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lichtenstein Mesh-Based HernioplastyProcedure or surgery
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 HernioplastyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Combined Modified Guarnieri-Desarda Tissue-Based Hernioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 2 weeks, 1 month, 3 months, and 6 months post-surgery.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: At 3 months post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Oct 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fadi Fawzi Azmi Khalil, Cairo University
- Investigators
- Fadi F. Khalil, MSc, Principal investigator, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595628
- Sponsor's protocol ID
- MD-255-2022
- Status last verified
- Mar 2025
- First submitted
- 10 Sep 2024
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Modified Guarnieri-Desarda Technique Versus Lichtenstein Technique in Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT06595628
- Acronym / sponsor ID
- MD-255-2022
- Conditions
- Inguinal Hernia
- Keywords
- Inguinal Hernia, Hernia Repair, Guarnieri Technique, Desarda Technique, Lichtenstein Hernioplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Lichtenstein Mesh-Based Repair | Active comparator | Procedure: Lichtenstein Mesh-Based HernioplastyParticipants 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. |
| Combined Modified Guarnieri-Desarda Tissue-Based Repair | Experimental | Procedure: Combined Modified Guarnieri-Desarda Tissue-Based HernioplastyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lichtenstein Mesh-Based HernioplastyThis 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. | Procedure or surgery | Lichtenstein Mesh-Based Repair |
| Combined Modified Guarnieri-Desarda Tissue-Based HernioplastyThis 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. | Procedure or surgery | Combined Modified Guarnieri-Desarda Tissue-Based Repair |
Primary outcome
Postoperative Pain Assessment
Time frame: At 2 weeks, 1 month, 3 months, and 6 months post-surgery.
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.
3 secondary outcomes
Incidence of Postoperative Complications
Time frame: At 2 weeks, 1 month, and 3 months post-surgery.
Hernia Recurrence Rate
Time frame: At 6 months and 1 year post-surgery.
Testicular Vascularity
Time frame: At 3 months post-surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fadi F. Khalil, MSc principal investigator
Kasr El Aini Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lichtenstein Mesh-Based Hernioplasty and Combined Modified Guarnieri-Desarda Tissue-Based Hernioplasty in people with Inguinal Hernia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fadi F. Khalil, MSc (01285612963 ext. +2, fady.azmi37080@postgrad.kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Assessment (time frame: At 2 weeks, 1 month, 3 months, and 6 months post-surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.