Non-Mesh Versus Mesh Method for Inguinal Hernia Repair

Study Overview
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Brief Summary
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The study aims at establishing the effectiveness of the non-mesh (Desarda) technique for the treatment of primary inguinal hernias at Mulago Hospital in Uganda. First developed and used in India, the Desarda method is reported to offer superior outcomes such as minimal postoperative groin pain and near zero recurrence rates. In comparison to the mesh-based repairs, it is a simple and affordable technique suitable for the resource-constrained communities. It is devoid of complications associated with foreign body implants. Early clinical outcomes which include acute groin pain, time to resumption of normal gait, operative time and complications will be assessed. Participants will be followed at 2 hours, 3 days, 7 days and 14 days postoperatively. The investigators hypothesize that the mean postoperative acute groin pain score, or the mean postoperative day of return to normal gait is different in adult patients who undergo the non-mesh (Desarda) repair from what it is in those who undergo the mesh (Lichtenstein) technique of hernia repair.

Official Title
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Comparison of Non-mesh (Desarda) and Mesh (Lichtenstein) Methods for Inguinal Hernia Repair at Mulago Hospital: a Double-blind Randomised Controlled Trial

Conditions
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Hernia, Inguinal

Intervention / Treatment
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* Procedure: Non-mesh Hernia Repair
* Procedure: Mesh Hernia Repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 and above; with a primary, reducible inguinal or inguino-scrotal hernia; who consent to participate in the study; who have a telephone contact. Exclusion Criteria: Giant inguino-scrotal hernias; Obstructive uropathy or chronic obstructive pulmonary disease; Impaired mental state and are unable to give an accurate assessment of the key outcomes of the operation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-mesh Hernia Repair<br>Reinforcement with a strip of external oblique aponeurosis | Procedure: Non-mesh Hernia Repair<br>* Non-mesh method for treatment of inguinal hernia without the use of a foreign material (mesh). It involves reinforcement of the weakened posterior wall of inguinal canal with a small, undetached strip of aponeurotic tissue of external<br>* Other names: Desarda repair;|
| Active Comparator: Mesh Hernia Repair<br>Polypropylene mesh placement | Procedure: Mesh Hernia Repair<br>* Mesh method for treatment of inguinal hernias by use of an implant (mesh) to reinforce the weakened posterior wall of the inguinal canal. The mesh is made of polypropylene material.<br>* Other names: Lichtenstein repair;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute groin pain after surgery (measured on pain visual analogue scale of 0-10) |  | 2 Weeks | 
| Time (in days) taken to return to normal gait |  | 2 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time (in Minutes) |  | 2 hours | 
| Complications during and after surgery |  | 2 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inguinal, Hernia, Hernia-repair, Non-mesh, Mesh, Desarda, Lichtenstein