Totally Extraperitoneal Repair of Groin Hernia in Liver Transplanted Patients (TOHER)

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

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.

Study Overview

• Status: Completed
• Conditions: Liver Cirrhosis; Liver Transplant Disorder; Groin Hernia
• Intervention / Treatment: Procedure: Totally Extraperitoneal Groin Hernia Repair

Detailed Description

This will be a single center prospective consecutive case series study. Liver transplanted patients diagnosed of groin hernia will be operated using endoscopic totally extraperitoneal approach in ambulatory surgery regimen. Main objective will be to evaluate the 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. Secondary objectives will be to record postoperative complications all along with quality standards criteria of ambulatory surgery.

The sample size could not be formally calculated as this is a pilot study. It is the first time that the surgical team has considered this type of surgical approach and we wish to evaluate the feasibility of this technique. Since in our center the number of surgical procedures of groin hernia in liver transplanted patients could be around 20 per year, for this pilot study we propose recruiting between 15-20 patients. The results will be representative of this type of surgical activities in a tertiary university hospital.

Liver transplanted patients diagnosed with groin hernia planned to undergo ambulatory surgical repair will be considered for being included in the study after informed consent. Perioperative management will be provided as determined by the local clinical practice without modifications due to study inclusion.The included patients will be prospectively registered in a standardized database. Background information and details regarding the surgery will be retrieved from the patients' medical records.

Information regarding postoperative complications will be collected up to 30 days after surgery. Following routine clinical practice, including telephonic contact on first postoperative 24h, clinical control follow up at 10 days and at month after the surgery.

This case series has been reported in line with the PROCESS Guideline.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic of Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Liver transplanted patients diagnosed with groin hernia planned to undergo ambulatory surgical repair will be considered for being included in the study after informed consent. Perioperative management will be provided as determined by the local clinical practice without modifications due to study inclusion.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

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).

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Investigators: Principal Investigator: Paula Dominguez-Garijo, MD, General Surgery, ICMDM, Hospital Clínic de Barcelona.

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2022
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Liver Trasplant; Groin Hernia; Totally Extraperitoneal Repair
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Pathological Conditions, Anatomical; Hernia, Abdominal; Fibrosis; Hernia; Hernia, Inguinal; Liver Cirrhosis
• Other Study ID Numbers: TOHER2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No