Mesh Alone VS Combined Mesh and Darn in the Management of Primary Inguinal Hernia in Adult Males

Study Overview
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Brief Summary
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A prospective randomized study involved 228 individuals with primary inguinal hernia, operated in our departments, between January 2015 to February 2018. The duration of hospital stay, operative time, duration of returning to routine activities, postsurgical sequels and recurrence rates estimated. We randomly allocated it into two groups: mesh repair was applied to 166 patients (Group 1) and combined both mesh, and darn repair applied to 162 patients (Group 2).

Detailed Description
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Background In spite of the era of laparoscopy still, open repair in primary inguinal hernia is currently the most commonly performed general surgical operation. To evaluate whether the combined darn repair plus Lichtenstein compare Lichtenstein repair alone in the treatment of inguinal hernias regarding postoperative complication and recurrence. Materials and methods: A prospective randomized study involved with 218 patients with primary inguinal hernia, operated in our departments, between 2015 and 2018. The duration of the operation time, hospitalization, and time to return to daily activities and postoperative complication and recurrence rates were evaluated. We randomly allocated into two groups: Lichtenstein repair was applied to 169 patients (Group 1), and combined both modified darn repair plus Lichtenstein repair was applied to 160 patients (Group 2). Results: The average follow-up period was 48 months. For the alone Lichtenstein procedure, the average duration of operation was 62 min; the average time to return to routine activities was 21 days. The number of patients with postoperative complications was 12 (11.3 %), and the number of patients with recurrence was 1 (0. 9%). For darn repair plus Lichtenstein procedure, the average duration of operation was 72 min; the time to return to daily activities was 21days. The number of patients with postoperative complication was 13 (11.6%), and no recurrences were noted. The hospitalization time of the groups was similar. Conclusion: Two-year follow-up, combined mesh and darn better than mesh alone in recurrence rate, both had the same postoperative complication, hospitalization time and return to routine activity.

Official Title
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Randomised Controlled Trial, Compare Mesh and Combined Mesh and Darn Repair in the Treatment of Adults Inguinal Hernia

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Procedure: polypropelene mesh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary hernia male Exclusion Criteria: Female bilateral recurrent hernia

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group II MA Mesh alone repair<br>patient use mesh alone as treatment of inguinal hernia | Procedure: polypropelene mesh<br>* compare use mesh alone or combined mesh and darn repair<br>|
| Active Comparator: Group I CMD Combined Mesh & darn<br>patients utilize both mesh and darn repair | Procedure: polypropelene mesh<br>* compare use mesh alone or combined mesh and darn repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate | follow up | two to four year | 
| Post operative complications | record complication | two to four year | 
| Post operative pain | Visual Analog Score for pain | two to four year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adult inguinal hernia, Mesh, Darn repair, Hernia repair techinques, Primary inguinal hernia