Totally Extraperitoneal Repair of Groin Hernia in Liver Transplanted Patients

NCT05378451 | Completed

• 1 other identifier: TOHER2021
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Transplant Disorder; Liver Cirrhosis; Groin Hernia

Keywords

Liver Trasplant; Groin Hernia; Totally Extraperitoneal Repair

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Rate of intraoperative complications

  0 days (intraoperative)

• Rate of postoperative complications

  30 days (postoperative)

• Pain measurement

  10 days (postoperative).

Interventions

Totally Extraperitoneal Groin Hernia Repair PROCEDURE

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.

Also known as: TEP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients older than 18 years of age.
• Liver transplanted patients diagnosed from groin hernia and proposed for ambulatory surgery.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic of Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Liver Cirrhosis; Hernia, Inguinal

Interventions

tetraethylpyrazine

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical

Study Officials

• Paula Dominguez-Garijo, MD

  General Surgery, ICMDM, Hospital Clínic de Barcelona.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 18, 2022
• Study Start: May 8, 2022
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: March 20, 2024

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

ES (1)