Comparison of Hernia Sac Ligation Versus Invagination

Study Overview
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Brief Summary
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Management of indirect hernial sac in inguinal hernia repairs has long been a subject of debate among general surgeons. Although hernial sac high ligation (HL) is a time-honored concept in groin hernia surgery, non-ligation/invagination is gaining more popularity. The aim of this study is to compare the effects of hernia sac ligation and invagination in patients with Lichtenstein mesh hernioplasty (LMH). Also, investigators aimed to investigate the possible association between the hernial defect size and postoperative early pain in both groups.

Official Title
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Comparison of Hernia Sac Ligation Versus Invagination in Lichtenstein Tension Free Mesh Hernioplasty. Does Type of Hernia Have a Role on Outcomes?

Conditions
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Hernia, Inguinal, Postoperative Pain, Recurrence

Intervention / Treatment
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* Procedure: Lichtenstein Mesh Hernioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: unilateral uncomplicated indirect hernia elective operations spinal anesthesia Exclusion Criteria: Bilateral hernias recurrent cases femoral-scrotal hernias those who refused to give consent those who were given general anesthesia besides spinal anesthesia those who were repaired with a method other than Lichtenstein mesh hernioplasty

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 |
| --- | --- |
| Active Comparator: high ligation<br>High ligation of the indirect hernia sac is traditional in inguinal hernia repairs. In this arm, patients with indirect inguinal hernia undergoing open mesh herniorrhaphy will have their hernia sac was opened and high ligated. | Procedure: Lichtenstein Mesh Hernioplasty<br>* The inguinal canal was opened and the hernia sac was dissected from the spermatic cord The deep inguinal ring was tightened with one or two polypropylene 2/0 sutures. The posterior wall of the inguinal canal was supported using the standard polypropylene mesh and fixed with 2/0 polyproline. The ilioinguinal nerve, iliohypogastric nerve, and genital branch of the genitofemoral nerve were preserved and care was taken to prevent entrapment.<br>|
| Experimental: non-ligation<br>In this arm, the patients' hernia sac will be dissected high but not opened or ligated. The sac will be invaginated to the abdomen. | Procedure: Lichtenstein Mesh Hernioplasty<br>* The inguinal canal was opened and the hernia sac was dissected from the spermatic cord The deep inguinal ring was tightened with one or two polypropylene 2/0 sutures. The posterior wall of the inguinal canal was supported using the standard polypropylene mesh and fixed with 2/0 polyproline. The ilioinguinal nerve, iliohypogastric nerve, and genital branch of the genitofemoral nerve were preserved and care was taken to prevent entrapment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain levels | 10-point Visual Analogue Scale (VAS) | postoperative period before discharge-1 year after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications | hematoma, seroma, wound infection, urinary retention | postoperative period before discharge (mainly the first 24 hours) | 
| perioperative outcomes | operative time (minutes), hospital stay (days) | postoperative period before discharge (mainly the first 24 hours) | 
| recurrence | Number of patients with hernia recurrence | postoperative 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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indirect hernia sac, ligation, invagination