- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06862167
Desarda's Technique Versus Lichtenstein's Technique Hernia Repair in Management of Elective Non-Complicated Inguinal Hernia
Comparative Study Between Desarda's Technique Versus Lichtenstein's Technique Hernia Repair in Management of Elective Non-complicated Inguinal Hernia (Randomized Controlled Trial)
Study Overview
Status
Intervention / Treatment
Detailed Description
Mesh prosthesis was introduced to hernial surgery as a magic solution for any inguinal hernia, and it has significant advantages (Simplicity of the procedure, Mesh is cheap, and has a low recurrence rate). Still, mesh induces fibrosis that can lead to stiffness and foreign body sensation, which become a source of agony for the patient. Mesh infection is one of the serious complications that can lead to the removal of the mesh and long-term terms morbidity from Lichtenstein hernia repairs, such as Vas entrapment and Chronic groin pain.
Desarda technique requires no extensive dissection or only suturing; no mesh is needed, and it is easy to learn. It is still ferrated and determined the optimum procedure to treat an inguinal hernia. It is a straightforward operation that avoids the risks of mesh implantation, has a low recurrence rate, and can be done by non-consultant staff.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minya Governorate
-
Minya, Minya Governorate, Egypt, 61611
- Minia University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Above 14 years of age.
- With reducible non-complicated inguinal or inguinoscrotal hernia; unilateral or bilateral
Exclusion Criteria:
- Obstructive uropathy or chronic obstructive pulmonary disease because they are contraindications to elective hernia surgery. They are associated with definite poor outcomes, such as high recurrence rates.
- Unfit patients for surgery
- Patients with strangulated hernia.
- Recurrent Hernias.
- Per operative finding of separated, thin, and/or weak external oblique aponeurosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Desarda's technique group
Patients will undergo Desarda's technique.
|
Patients will undergo Desarda's technique.
|
|
Active Comparator: Lichtenstein's technique group
Patients will undergo Lichtenstein's technique.
|
Patients will undergo Lichtenstein's technique.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of postoperative complications
Time Frame: 1 year postoperatively
|
Incidence of postoperative complications such as groin pain, hemorrhage, orchitis, testicular atrophy, and seroma will be recorded.
|
1 year postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time till stop of postoperative analgesic
Time Frame: 30 days postoperatively
|
Stop of postoperative analgesic (Within 3 days, 3 to 6 days, More than 6 days)
|
30 days postoperatively
|
|
Return to normal activity
Time Frame: 30 days postoperatively
|
Return to normal activity will be recorded from 1 to 7 days, 8 to 15 days, and 16 to 30 days postoperatively.
|
30 days postoperatively
|
|
Incidence of recurrence
Time Frame: 1 year postoperatively
|
Incidence of recurrence will be recorded within 1 year postoperatively
|
1 year postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1240/08/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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