Liver Cirrhosis Clinical Trial
— TOHEROfficial title:
Totally Extraperitoneal Repair of Groin Hernia in Liver Transplanted Patients: a Case Series Study. (TOHER)
NCT number | NCT05378451 |
Other study ID # | TOHER2021 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 8, 2022 |
Est. completion date | January 1, 2024 |
Verified date | May 2022 |
Source | Hospital Clinic of Barcelona |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | January 1, 2024 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clinic of Barcelona | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital Clinic of Barcelona |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Rate of intraoperative complications | Register intraoperative complications (intestinal lesions, urinary bladder lesions, major vascular lesions...) | 0 days (intraoperative) | |
Secondary | Rate of postoperative complications | Register postoperative complications (acute urinary retention, urinary infection, hematoma, seroma, surgical wound infection...) | 30 days (postoperative) | |
Secondary | 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). |
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