Comparative Study Between Lap. Dual Approach, Lap. Trans Abdominal Pre-peritoneal and Lichtenstein Procedures

Study Overview
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Brief Summary
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This study designed to compare the new laparoscopic dual approach to inguinal hernia repair with trans-abdominal preperitoneal (TAPP) and lichtenstein repair (open procedure)

Detailed Description
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inguinal hernioplasty is a procedures where synthetic mesh is used to strengthen the inguinal tissues sites for hernia repair different methods used which is either anterior approach (open Lichtenstein) or laparoscopic posterior approach through the abdomen (TAPP) comparing these two methods by new approach which is considered to some extent a modified TAPP by pneumo-dissection of pre-peritoneal space with abdominal approach by lap. repair

Official Title
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Inguinal Hernioplasty: Comparative Study Between Laparoscopic Dual Approach, Laparoscopic Trans Abdominal Preperitoneal and Lichtenstein Procedures. A Prospective Randomized Controlled Trial

Conditions
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Inguinal Hernioplasty

Intervention / Treatment
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* Procedure: dual approach laparoscopic inguinal hernioplasty
* Procedure: TAPP
* Procedure: (lichtenstein) repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult male patient (older than 18y). Not complicated. No previous lower abdominal incisions (lower abdominal midline and lower paramedian incision in the same side of hernia). No contraindication for general anesthesia. Not recurrent. Exclusion Criteria: any one not in fulfill inclusion criteria

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
Interventional Model Description: comparative study between three procedures of inguinal hernioplasty; open (LICHTENSTEIN), TAPP, and laparoscopic DUAL APPROACH (modified TAPP)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A (dual approach lap hernioplasty)<br>dual approach laparoscopic inguinal hernioplasty by combination of TAPP (group B) and pneumo-dissection preperitoneal instead of sharp dissection | Procedure: dual approach laparoscopic inguinal hernioplasty<br>* after pneumoperitoneum is done preperitoneal pneumo-dissection is done and then peritoneal incision done . dissection preperitoneally and sac dissection will be easy approached<br>|
| Active Comparator: group B (TAPP)<br>trans-abdominal preperitoneal hernioplasty (TAPP) after induction of pneumoperitoneum through peritoneal approach peritoneal incision and preperitoneal dissection then mesh fixation done | Procedure: TAPP<br>* pneumoperitoneum is done and then through abdominal approach peritoneal dissection in done and sac reduction and then mesh fixation<br>|
| Active Comparator: group C (Lichtenstein hernioplasty)<br>open inguinal hernioplasty (lichtenstein) repair through inguinal incision and dissection of the sac anteriorly , excision of the sac and then mesh fixation in the posterior wall of inguinal canal | Procedure: (lichtenstein) repair<br>* inguinal incision is done and inguinal canal approach anteriorly and then sac dissection and excision then mesh fixation to posterior wall and closure the incision in layers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative time | operative time will be measured in minutes for each procedure.and comparing three groups ( dual approach , TAPP and Lichtenstein ) in operative time which determined as follow: from the inflation of the abdomen till deflation and port closure for Lichtenstein from skin incision to skin closure | from the inflation of the abdomen till deflation and port closure ---for lichtenstein from skin incision to skin closure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative injuries | abdominal visceral injuries cord structure injuries | intra operative | 
| intra operative bleeding | mild bleeding and oozing controlled by cautery bleeding from inferior epigastric artery or testicular artery major vascular injury | intraoperative | 
| post operative pain | pain measured by visual analog scale from 0 no pain to 10 the worst pain ever. | immediately post operative and 6 ,12, 24 hours and two weeks post operative | 
| post operative wound complication | wound seroma , hematoma either small with conservative treatment and large need intervention wound infection either superficial skin and S.C. or mesh infection | 2 weeks post operative ,3 ,6 and 12 months postoperative | 
| post operative chronic pain | post operative paraesthesia , bricking pain, dull-aching pain. measured by visual analog scale (VAS) from 0 no pain to 10 the worst pain ever | follow up at 3 months , 6 months and one year for pain assessment by VAS | 
| recurrence | post operative inguinal swelling confirmed clinically as a recurrent hernia | 3 months, 6 months and one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dual approach, laparoscopic hernioplasty