Laparoscopic Transabdominal Preperitoneal Surgical Repair of Inguinal Hernia Using Sutured Repair Versus Tacker Use

Study Overview
=================
Brief Summary
-----------------
Background: Mesh fixation is a critical step in laparoscopic Transabdominal Preperitoneal (TAPP) hernia repair because fixation is a significant step to prevent the hazard of mesh migration, but is supposed to be associated with a higher risk of acute and chronic pain compared with non-fixation. Fixation is more expensive than non-fixation. Objective: To compare the efficiency of mesh fixation in laparoscopic TAPP surgical repair of inguinal hernia using sutured repair versus tacker use. Patients and Methods: This prospective randomized comparative study was carried out on 60 patients who presented with a unilateral inguinal hernia and were assigned to laparoscopic TAPP hernia repair. Patients were randomly allocated into two equal groups (30 patients each); in group A, the mesh was fixed with a Titanium tacker, and in group B, the mesh was sutured and fixed with polypropylene 0.

Official Title
-----------------
Laparoscopic Transabdominal Preperitoneal Surgical Repair of Inguinal Hernia Using Sutured Repair Versus Tacker Use

Conditions
-----------------
Inguinal Hernia Unilateral

Intervention / Treatment
-----------------
* Other: Titanium tacker
* Other: Polypropylene 0


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 21 years American Society of Anesthesiologists (ASA) physical status ≤ II Patients with body mass index (BMI) of 25 to 35 kg/m² Unilateral inguinal hernia Exclusion Criteria: Age < 21 years ASA physical status > II Patients with body mass index (BMI) > 35 kg/m² Pregnant women Bilateral inguinal hernia Large inguinoscrotal hernia Incarcerated hernia Recurrent hernia Strangulated hernia Prostatic diseases History of; Convulsions, Cerebrovascular accident, Previous neurological diseases Dysrhythmia Hypertension Ischemic heart disease Hyperthyroidism Liver or Renal impairment Alcohol or drug abuse

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Titanium tacker group (n=30)<br>Group A | Other: Titanium tacker<br>* Mesh fixation with Titanium tacker<br>|
| Active Comparator: Polypropylene group (n=30)<br>Group B | Other: Polypropylene 0<br>* Mesh was sutured and fixed with polypropylene 0<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median and Range of Numeric Pain Rating Scale (NPRS) score [(median (range)] | NPRS measures the severity of postoperative pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (2h, 6h, 12h, 24h, 48h, 72h, and 7 days) | 7 days after the end of the operation | 
| Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD) | NPRS measures the severity of postoperative pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (2h, 6h, 12h, 24h, 48h, 72h, and 7 days) | 7 days after the end of the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean and Standard deviation of Operative duration (minutes) (mean±SD) | Time from skin incision till skin closure | 2 minutes after the end of the operation | 
| Mean and Standard deviation of Length of hospital stay (hours) (mean±SD) | Time from hospital admission till discharge | 24 hours after the end of the operation | 
| Number of participants and Rate of Intraoperative complications | Number of participants and Rate of: Bowel injury, Injury to inferior epigastric artery, Injury to major vessels, Bleeding of venous plexus around pubic bone, Injury to vas deferens, Bladder injury. | 2 minutes after the end of the operation | 
| Number of participants and Rate of Postoperative complications | Number of participants and Rate of: Cord edema, Seroma, Port-site infection, Inguinal anesthesia/hyperthesia, Chronic pain, Recurrence. | 1 year after the end of the operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inguinal hernia, Mesh fixation, Titanium tacker