Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia

Study Overview
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Brief Summary
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The best approach for simultaneous repair of bilateral inguinal hernia is controversial. The aim of this study is to compare the outcomes after laparoscopic versus open mesh repair of bilateral primary inguinal hernia

Detailed Description
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This prospective study included 180 patients with bilateral primary inguinal hernia; randomized by sealed envelopes into 3 groups; each includes 60 patients. Group I treated by laparoscopic trans-abdominal pre-peritoneal (TAPP) repair using 2 separate meshes, Group II treated by open pre-peritoneal (PP) single mesh repair, while Group III treated by bilateral Lichtenstein repair. The 3 groups were compared regarding: operative time, postoperative complications, postoperative pain, 3 years-recurrence rate and patient's satisfaction. .

Official Title
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Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia; 3 Armed Randomized Study

Conditions
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Bilateral Inguinal Hernia

Intervention / Treatment
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* Procedure: Laparoscopic Trans-Abdominal Pre-Peritoneal
* Procedure: Open pre-peritoneal repair
* Procedure: Bilateral Lichtenstein repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with painless uncomplicated primary bilateral inguinal hernias Exclusion Criteria: Immune compromised patients Coagulopathy Chronic liver or renal disease High-risk patients unfit for major surgery (ASA III or IV), Massive scrotal hernias, Recurrent or Complicated hernias Groin pain due to any other pathology Previous infra-umbilical surgery

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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: Laparoscopic Trans-Abdominal Pre-Peritoneal (Lap TAPP group))<br>Both hernias were treated by laparoscopic trans-abdominal pre-peritoneal repair using 2 separate meshes fixed by endoscopic tackers | Procedure: Laparoscopic Trans-Abdominal Pre-Peritoneal<br>* Laparoscopic trans-abdominal pre-peritoneal repair using 2 separate meshes fixed by endoscopic tackers<br>|
| Active Comparator: Open Pre-Peritoneal Repair ( Open PP group)<br>Both hernias were treated by open pre-peritoneal single mesh repair with suture fixation | Procedure: Open pre-peritoneal repair<br>* Open pre-peritoneal single mesh repair with suture fixation<br>|
| Active Comparator: Bilateral Lichtenstein repair (LICHT group)<br>treated by bilateral standard Lichtenstein repair using 2 separate meshes with suture fixation | Procedure: Bilateral Lichtenstein repair<br>* Bilateral standard Lichtenstein repair using 2 separate meshes with suture fixation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | Operative time (in minutes) | From skin incision until incision closure at the end of surgery | 
| Postoperative pain after 24 hours | Pain intensity was assessed 24 hours after surgery using the pain visual analogue scale (VAS) with values ranging from 1 (no pain) to 10 (worst possible pain) | 24 hours after surgery | 
| Postoperative pain after 7 days | Pain intensity was assessed 7 days after surgery using the pain visual analogue scale (VAS) with values ranging from 1 (no pain) to 10 (worst possible pain) | 7 days after surgery | 
| Early postoperative complications | All complication related to surgery developed within 30 days after the surgery | Within 30 days after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic Groin pain | Groin pain lasting for more than 3 months after surgery | After 3 months postoperatively | 
| 3 years hernia recurrence rate | Unilateral or bilateral - residual or recurrent hernia | within 3 years after surgery | 
| Patient's satisfaction score | Patient satisfaction was assessed using 1 to 10 scale where: 9-10 means very satisfied, 7-8: satisfied, 6-7: neutral, 4-5: dissatisfied, <4: very dissatisfied | within 3 years after surgery |