LESS TEP vs. Three Port TEP for Inguinal Hernia Repair

Study Overview
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Brief Summary
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This study aim to compare efficacy and safety of Laparoendoscopic single site total extraperitoneal inguinal hernia repair /LESS TEP/ and traditional total extraperitoneal hernia repair with 3 ports /TEP/.

Detailed Description
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This is a prospective, double blinded, randomized trial. It compared of Laparoendoscopic single site total extraperitoneal inguinal hernia repair /LESS TEP/ and traditional total extraperitoneal hernia repair with 3 ports /TEP/. Inguinal hernia is one of the most common surgical diseases. Laparoscopic hernia repairs include two types, TEP and TAPP. Laparoscopic inguinal hernia repair was associated with less post operative pain, a shorter recovery period and better cosmetic results. Efforts are continuing to further reduce the port related morbidities and improve the cosmetic outcomes of laparoscopic surgery, including reduction of the size and number of ports. This has led to the evolution of a novel surgical approach now collectively known as laparoendoscopic single-site surgery. 200 patients will undergo TEP inguinal hernia repair. They will be randomized in two groups by sealed envelope method. Group A: Standard TEP with 3 ports (10mm. and 2 ports of 5mm.). In case of difficulty in Standard 3 port TEP inguinal hernia repair, the procedure will be converted to TAPP. Group B: LESS TEP with single skin incision 2-3cm. In case of difficulty in LESS TEP inguinal hernia repair, the procedure will be converted to standard 3 port repair or TAPP. 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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Laparoendoscopic Single-site Versus Three Port Totally Extraperitoneal Hernia Repair: A Prospective Double Blinded Randomized Clinical Trial

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Procedure: Standard 3 port TEP
* Procedure: LESS TEP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 90 years Willing to participate in this study and signed an informed consent. Diagnosed inguinal hernia - primary or recurrence ASA class I, II and III Exclusion Criteria: Age under 18 years and above 90 years Strangulated hernia Patients with severe chronic diseases or cardiopulmonary dysfunction, who can't undergo general anesthesia Patients who prefer a certain surgical approach Patients who undergo surgery procedures for chronic pain after inguinal hernia repair

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard 3 port TEP<br>Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ). | Procedure: Standard 3 port TEP<br>* 3 port TEP inguinal hernia repair with 10mm. port under the umbilicus and two 5mm. port in line under the 10mm. port<br>|
| Active Comparator: LESS TEP<br>Group B will undergo laparoscopic TEP inguinal hernia repair with a single skin incision 2-3cm. | Procedure: LESS TEP<br>* TEP inguinal hernia repair with one vertical skin incision under the umbilicus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain | Assessment of post-operative pain according to the visual analog scale pain score - From 0 to 10 - 0 is no pain and 10 is severe pain. | 24hours | 
| Postoperative Pain | Assessment of post-operative pain according to the visual analog scale pain score - From 0 to 10 - 0 is no pain and 10 is severe pain. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operating time |  | During operation | 
| Intraoperative complications | Assessment of interoperation procedure of the incident of spermaduct, vessel and other organ damage | During operation | 
| Length of hospital stay |  | 24 hours | 
| Postoperative complications | Urinary infections; Seroma; Hematoma | 1 week; 4 weeks | 
| Recurrence of hernia |  | 4 weeks; 3 months; 1 year | 
| Cosmetic scar score | Scar evaluation using Patient and Observer Scar Assessment Scale (POSAS) 4 week after the surgery | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TEP, LESS TEP, Inguinal Hernia, Laparoscopic Surgery, Recurrence inguinal hernia, Primary inguinal hernia