SIngle Port vs Standard TEP for Primary Inguinal Hernia Repair

Study Overview
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Brief Summary
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This study is carried out to determine if laparoscopic inguinal TEP repair of the hernia using a mesh carried out with only 1 port (hole) results in the reduction of post- operative pain and use of painkillers, shorter hospital stay and lesser complications than that carried out using conventional 3 ports.

Detailed Description
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100 patients undergoing laparoscopic TEP ( Total extraperitoneal repair) inguinal hernia repair under general anaesthesia will be randomized into 2 groups by the closed envelope method. In case of difficulty in Single port TEP inguinal hernia repair, the procedure will be converted to conventional 3 port repair for patient safety. 2 groups of participants: Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ). Group B will undergo laparoscopic TEP inguinal hernia repair with a single port (12 to 15 mm transumbilical). Patient will be informed at consenting that 3 wound plasters will be applied to their abdomen regardless of whether they are in the single port or 3- ports group so that they would not know which group they have been randomized to. The blind will only be lifted after pain score and area of pain has been recorded before discharge.

Official Title
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A Prospective, Randomized, Controlled Trial to Compare Single Port Laparoscopic TEP Inguinal Hernia Repair Versus Standard Laparoscopic (3 Port) TEP Inguinal Hernia Mesh Repair

Conditions
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Primary Unilateral Inguinal Hernia

Intervention / Treatment
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* Procedure: Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm )
* Procedure: Group B will undergo laparoscopic TEP inguinal hernia repair with a single port


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 21- 80 yrs Informed consent Diagnosis of Hernia ASA I and II BMI<25. Exclusion Criteria: Bleeding disorders Age below 21 Strangulated Hernia BMI > 30 Incarcerated and obstructed hernia Recurrent hernia Bilateral hernia Previous LSCS Previous lower abdominal surgery

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group A: Standard TEP<br>Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ). | Procedure: Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm )<br>* laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ).<br>|
| Active Comparator: Group B: LESS Port<br>Group B will undergo laparoscopic TEP inguinal hernia repair with a single port (12 to 15 mm transumbilical). | Procedure: Group B will undergo laparoscopic TEP inguinal hernia repair with a single port<br>* Group B will undergo laparoscopic TEP inguinal hernia repair with a single port LESS (12 to 15 mm transumbilical).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score (Visual Analog Scale) at 24hours after surgery | Assessment of post-operative pain according to the visual analog scale Pain score will be taken, and painkiller consumption will be recorded | 24 hours | 
| Pain score (Visual Analog Scale) at 1 week after surgery | Assessment of pain according to the visual analog scale | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of inguinal hernia | Finding of hernia again during examination after surgery | 1-3-6 months | 
| Post-operative complications | Examining for any seroma, hematoma and skin ecchymosis | 1-3-6 months | 
| Pain score (Visual Analog Scale) at 1-3-6 months after surgery | Assessment of pain according to the visual analog scale | 1-3-6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inguinal Hernia, Primary, laparoscopic surgery, single port surgery