TOHER: Totally Extraperitoneal Repair of Groin Hernia in Liver Transplanted Patients

Sponsor
Hospital Clinic of Barcelona (Other)
Overall Status
Recruiting
CT.gov ID
NCT05378451
Collaborator
(none)
12
1
23.8
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Totally Extraperitoneal Groin Hernia Repair

Study Design

Study Type:
Observational
Anticipated Enrollment :
12 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Totally Extraperitoneal Repair of Groin Hernia in Liver Transplanted Patients: a Case Series Study. (TOHER)
Actual Study Start Date :
May 8, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
May 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Rate of completion of surgery by totally extraperitoneal approach [0 days (intraoperative)]

    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 Outcome Measures

  1. Rate of intraoperative complications [0 days (intraoperative)]

    Register intraoperative complications (intestinal lesions, urinary bladder lesions, major vascular lesions...)

  2. Rate of postoperative complications [30 days (postoperative)]

    Register postoperative complications (acute urinary retention, urinary infection, hematoma, seroma, surgical wound infection...)

  3. Pain measurement [10 days (postoperative).]

    Control of pain assessed by Visual Analogue Score (at time of discharge, first postoperative day and after 10 days of surgery).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Clinic of Barcelona Barcelona Spain 08036

Sponsors and Collaborators

  • Hospital Clinic of Barcelona

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT05378451
Other Study ID Numbers:
  • TOHER2021
First Posted:
May 18, 2022
Last Update Posted:
May 18, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospital Clinic of Barcelona
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2022