Hernia Repair Four Arm Comparative Study

Study Overview
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Brief Summary
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This study compares the outcome of the four most commonly used operations for the repair of primary groin hernia including the new key hole surgical techniques. It aims at answering the question of whether the new technology really improve the outcome, saves time and reduce patient suffering.

Detailed Description
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The study compares two traditional techniques of inguinal hernia repair; namely Lechtenstien repair and properitoneal repair versus two techniques of laparoscopic hernia repair, namely extraperitoneal and transperitoneal repair. It compares the operative time, complications, postoperative pain and the speed of patient recovery.

Official Title
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Four Arm Randomised Trial Comparing Laparoscopic And Open Hernia Repairs

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Procedure: open properitoneal hernia repair
* Procedure: Lechtestien hernia repair
* Procedure: Laparoscopic transperitoneal approach
* Procedure: Laparoscopic totally extraperitoneal approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult male primary inguinal hernia Exclusion Criteria: recurrent hernia previous lower abdominal surgery [excluding appendectomy]
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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: open properitoneal<br>patients undergoing open properitoneal hernia repair | Procedure: open properitoneal hernia repair<br>* suprapubic retro-inguinal approach<br>* Other names: extraperitoneal repair;|
| Active Comparator: Lechtenstien repair<br>Patients undergoing Lechtestien hernia repair | Procedure: Lechtestien hernia repair<br>* onlay mesh repair<br>* Other names: tension free repair;|
| Active Comparator: Laparoscopic transperitoneal repair<br>Patients undergoing TAPP repair | Procedure: Laparoscopic transperitoneal approach<br>* intraperitoneal insufflation followed by re-exiting to the hernia site<br>* Other names: TAPP;|
| Active Comparator: Lap totally extraperitoneal approach<br>Patients undergoing TEP approach | Procedure: Laparoscopic totally extraperitoneal approach<br>* avoiding the peritoneum altogether<br>* Other names: TEP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient ability to resume domestic activity independently |  | daily reporting by the patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of the patient to return to work |  | reported by the patient | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minimally invasive, Inguinal hernia, Pro-peritoneal repair