Tissue Glue vs Metallic Tackers in Mesh Fixation During TAPP Repair.

Study Overview
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Brief Summary
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This is a randomized control trial intending to study the clinical difference between different mesh fixation techniques in laparoscopic TAPP hernioplasty of inguinal hernia for adults with unilateral and bilateral inguinal hernia , two techniques are tissue glue and surgical tackers , the target population will be divided according to an electronic generated randomization into two groups , they will be compared according to multiple variables which includes but not limited to : procedure time, early post op complication , post-operative pain , late complications , short term and long term recurrence rates .

Detailed Description
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Laparoscopic transabdominal preperitoneal ( TAPP ) hernioplasty has emerged as an essential procedure for adults complaining of both unilateral and bilateral inguinal hernia , various descriptions of the procedure have been published recently, complications and recurrence rates are being calculated for each method, different mesh fixation techniques are being used by different surgeons, some use surgical tackers, some use fibrin glue and some demonstrated an equal outcome if the mesh was not fixed at all. This is a randomized control trial intending to study the clinical difference between those different mesh fixation techniques in laparoscopic TAPP hernioplasty of inguinal hernia for adults with unilateral and bilateral inguinal hernia , two techniques are tissue glue and surgical tackers , the target population will be divided according to an electronic generated randomization into two groups , they will be compared according to multiple variables which includes but not limited to : procedure time, early post op complication , post-operative pain , late complications , short term and long term recurrence rates .

Official Title
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A Randomized Controlled Trial Studying Tissue Glue vs Metallic Tackers in Mesh Fixation During TAPP Repair.

Conditions
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Hernia

Intervention / Treatment
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* Procedure: tissue Glue for mesh fixation
* Procedure: Metallic Tackers for mesh fixation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all Adult Patients ages between 18 and 80 years old, males and females, inguinal hernias, unilateral or bilateral and femoral hernias. Exclusion Criteria: operations which were converted from TAPP to other procedures (such as open repair or TEP). Patients who were unfit for general anesthesia patients who refused to participate in the study patients with chronic pain disorders requiring long term pain management before the procedure. cases with complicated hernias that required emergency repair.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

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
Interventional Model Description: randomized control trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tissue glue<br>mesh fixed using tissue glue | Procedure: tissue Glue for mesh fixation<br>* one arm of the study had their mesh fixed with tissue glue applied at multiple sites<br>|
| Experimental: metallic tackers<br>mesh fixed using metallic tackers | Procedure: Metallic Tackers for mesh fixation<br>* in the other arm mesh was fixed with tackers applied avoiding the triangle of pain and the triangle of doom using a three point fixation technique; Cooper's ligament, medial cranial edge of the mesh and just lateral to the inferior epigastric vessels.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | postoperative pain was measured using The visual analog scale ( VAS ) scored from 1-10 | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications | postoperative complications including : seroma, ssi , hematoma and others | 6 weeks | 
| operative time | operative time | intraoperative | 
| hospital stay | postoperative days in hospital measured | 6 WEEKS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tackers, Laparoscopic TAPP, tissue glue, hernia