Totally Extraperitoneal Repair of Groin Hernia in Liver Transplanted Patients

Study Overview
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Brief Summary
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Liver transplant recipients share the risk with cirrhotic patients for the development of inguinal hernias, but their liver failure pathophysiology has reversed following transplantation. Despite immunosuppression alters wound healing and infections, inguinal hernia repair in transplanted patients has shown better outcome compared to cirrhotic patients. Endoscopic inguinal hernia techniques have proved to be superior to open repair, due to lower incidence of postoperative complications and short-term convalescence, but there is no evidence of the use of this approach in liver transplanted patients. This prospective consecutive case series study will be the first study to describe the postoperative results of groin hernia repair in ambulatory surgery regimen in liver transplanted patients using totally extraperitoneal approach. The included patients will be prospectively registered in a standardized database. Rate of completion of surgery by totally extraperitoneal approach without the needing of conversion to anterior open approach or transabdominal preperitoneal approach due technical difficulties will be evaluated. Postoperative complications all along with quality standards criteria of ambulatory surgery will be reported for descriptive purposes.

Official Title
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Totally Extraperitoneal Repair of Groin Hernia in Liver Transplanted Patients: a Case Series Study. (TOHER)

Conditions
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Liver Transplant Disorder, Liver Cirrhosis, Groin Hernia

Intervention / Treatment
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* Procedure: Totally Extraperitoneal Groin Hernia Repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years of age. Liver transplanted patients diagnosed from groin hernia and proposed for ambulatory surgery. Signed informed consent for inclusion in the study Exclusion Criteria: Patients under 18 years of age. Pregnancy or breastfeeding. Inability to give informed consent. Patients not candidates for surgical treatment. Contraindication to general anesthesia. Procedures performed in an emergency setting. Patients non tributary to ambulatory surgery due to anesthesia management (ASA>III or decompensation in the last 3 months) Impossibility for the care of a responsible adult during first 24 hours after surgery. Domicile at a distance of more than 1 hour by vehicle from the hospital. Previous posterior approach for hernia repair. Previous cystectomy and prostatectomy surgery.

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Totally Extraperitoneal Groin Hernia Repair|Patients will undergo totally extraperitoneal groin hernia repair, by a single senior experimented surgeon and without modifications from the routine clinical practice due to study inclusion. TEP approach will be assessed by placement of 3 trocars in the lower midline. Preperitoneal space will be dissected under direct vision using Spacemaker Dissection Balloon (Applied Medical®). Systematic complete dissection of the myopectineal orifice, Retzius and Bogros spaces will be performed to identify all potential sites of hernia formation. It will be used a laparoscopic self-fixating mesh (ProGrip™). Preperitoneal instillation of local anesthesia (15 mL of 0.5% bupivacaine) will be placed placed by the surgeon under direct visualization into triangle of pain. Local anesthesia (levobupivacaine 10mL 1%) will be applied in all the incisions.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of completion of surgery by totally extraperitoneal approach | Rate of completion of surgery by totally extraperitoneal approach without the needing of conversion to anterior open approach or transabdominal preperitoneal approach due technical difficulties. | 0 days (intraoperative) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of intraoperative complications | Register intraoperative complications (intestinal lesions, urinary bladder lesions, major vascular lesions...) | 0 days (intraoperative) | 
| Rate of postoperative complications | Register postoperative complications (acute urinary retention, urinary infection, hematoma, seroma, surgical wound infection...) | 30 days (postoperative) | 
| Pain measurement | Control of pain assessed by Visual Analogue Score (at time of discharge, first postoperative day and after 10 days of surgery). | 10 days (postoperative). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver Trasplant, Groin Hernia, Totally Extraperitoneal Repair