Clinical Trial to Compare TAPP (Transabdominal Preperitoneal) vs TEP (Totally Extraperitoneal) y Approach for Women's Inguinal Hernia on an Outpatient Basis

Study Overview
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Brief Summary
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Open prospective randomised clinical trial enrolling women who suffer from inguinal or femoral hernia, to evaluate if TEP approach is superior to TAPP concerning postoperative development, principally postoperative pain, with no increase of recurrent hernia at the one-year follow-up visit.

Detailed Description
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Randomised phase IV clinical trial enrolling women suffering from inguinal hernia in Virgen del Rocío University Hospital influence area, from March 2019 to March 2021. The aim of the study is to conclusively stablish whether there is real and significant benefit in using TEP approach over TAPP, in an outpatient basis, concerning postoperative evolution. Secondary objectives are the assessment of postoperative pain, using VAS (visual analogic scale), of both techniques, and evaluation of hernia recurrence during the first postoperative year The individuals will be assigned to each group according to simple random sampling.

Official Title
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Randomized Clinical Trial to Compare TAPP vs TEP Approach for Women's Inguinal Hernia on an Outpatient Basis

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Procedure: TAPP
* Procedure: TEP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inguinofemoral hernia, EHS (European Hernia Society) classification. Patient over 18 years old. Signed informed consent form. Female Meeting of outpatient discharge criteria, determined by Aldrete´s test Exclusion Criteria: Loss of domain. Abdominal skin grafts. Previous preperitoneal (open or laparoscopic) prosthetic mesh. Incarcerated hernia. Previous complications such as infection, fistulae… Not candidate for ambulatory surgery Pregnancy or desire for pregnancy in the first postoperative year

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TAPP (Trans Abdominal PrePeritoneal)<br>Trans Abdominal PrePeritoneal approach to inguinal hernia repair | Procedure: TAPP<br>* Trans Abdominal Pre Peritoneal approach<br>|
| Experimental: TEP (Totally Extra Peritoneal)<br>Totally Extra Peritoneal approach to inguinal hernia repair | Procedure: TEP<br>* Total Extra Peritoneal approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative pain | Post operative pain, measured with Visual Analogue Scale (VAS) (from 0 to 10 points) World Health Organization (WHO) | 24 hours | 
| Recurrence | Recurrence of inguinal hernia in the one-year follow-up | One year | 
| Complications | Postoperative complications including wound complications (seroma, haematoma, infection), gastrointestinal complications (ileus, fistula), urological complications (acute retention, haematuria) and hernia complications (recurrence, chronic groin pain) will be reported. Occurrence of major complications will be registered, including intestinal injury, major vascular lesion, bleeding over 500cc and peritonitis. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operating time | Operating time from first incision to closure | 180 minutes | 
| Hospital stay | length of hospital stay will be measured in hours between the end of the surgery and the time of discharge. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Woman, Inguinal Hernia, TAPP, TEP, Outpatient Surgery, Ambulatory Surgery