Laparoscopic Versus Open Repair of Bilateral Primary Inguinal Hernia

Study Overview
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Brief Summary
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Currently, there is a controversy regarding the best approach for simultaneous repair of bilateral inguinal hernia. The aim of this study was to compare the outcome of laparoscopic versus open repair of bilateral inguinal hernia

Detailed Description
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This prospective randomized study included 120 consecutive patients with bilateral primary inguinal hernia treated at Alexandria university hospital in the period between June 2014 and February 2017. Patients were randomized by sealed envelopes into 3 groups, each includes 40 patients. Group I treated by laparoscopic transabdominal preperitoneal repair using 2 separate meshes, Group II treated by open preperitoneal mesh repair, while Group III treated by bilateral Lichtenstein repair. The 3 groups were compared regarding: operative time, postoperative complications, pain, hospital stay, return to normal activity and work, chronic groin pain, patient's satisfaction and 3 years recurrence rate. Statistical Analysis: Numerical data in both groups was expressed as mean ± standard deviation (SD) and compared using One-way analysis of variance while categorical data was expressed as percentages and compared using Chi-squared test. Logistic regression test was used to determine predictors of postoperative complications. Differences were considered significant at p <0.05.

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

Conditions
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Bilateral Inguinal Hernia, Postoperative Complications

Intervention / Treatment
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* Procedure: Bilateral TAPP Repair
* Procedure: Open PP Repair
* Procedure: Bilateral Lichtenstein Repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with primary bilateral inguinal hernias in patients aged from 20 to 60 years Exclusion Criteria: - Immune compromised patients, - Morbid obesity (BMI > 35 kg/m2) - Chronic liver or renal disease - Coagulopathy - High-risk patients unfit for major surgery (ASA III or IV) - Recurrent hernias - Complicated hernias - Massive scrotal hernias - Previous infra-umbilical surgery Persistent groin pain due to other causes

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 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
Interventional Model Description: This prospective study included 120 consecutive patients with bilateral primary inguinal hernia managed by simultaneous bilateral repair. Patients were randomized by sealed opaque envelopes containing computer generated random numbers into 3 groups, each includes 40 patients. Group I treated by laparoscopic transabdominal preperitoneal repair using 2 separate meshes (Lap TAPP), Group II treated by open preperitoneal mesh repair with mesh fixation (Open PP), while Group III treated by standard bilateral Lichtenstein repair (LICHT group).
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lap TAPP Group<br>Patients treated by laparoscopic transabdominal preperitoneal repair using 2 separate meshes fixed by laparoscopic tackers | Procedure: Bilateral TAPP Repair<br>* laparoscopic transabdominal preperitoneal repair using 2 separate meshes fixed by laparoscopic tackers<br>|
| Active Comparator: Open PP Group<br>Patients treated by open preperitoneal single mesh repair fixated using sutures | Procedure: Open PP Repair<br>* Open pre-peritoneal repair using single mesh fixed by sutures<br>|
| Active Comparator: Bilateral LICHT Group<br>Patients treated by standard bilateral Lichtenstein repair using 2 separate meshes fixed by sutures | Procedure: Bilateral Lichtenstein Repair<br>* Bilateral Lichtenstein Repair using 2 separate meshes fixed by sutures<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) | Same day of surgery | 
| Postoperative pain 7 days after surgery | Pain intensity was assessed 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 | Any complications related to surgery developed within 30 days after the surgery | 30 days after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic postoperative pain | Groin pain related to surgery lasting for more than 3 months after surgery | 3 months after surgery | 
| Hernia recurrence | Unilateral or bilateral - residual or recurrent hernia within 3 years after surgery | 3 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bilateral Inguinal Hernia, Laparoscopic versus open mesh repair, Operative outcomes, Recurrence