Status:
UNKNOWN
Clinical Trial to Compare TAPP (Transabdominal Preperitoneal) vs TEP (Totally Extraperitoneal) y Approach for Women's Inguinal Hernia on an Outpatient Basis
Lead Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Conditions:
Inguinal Hernia
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Open prospective randomised clinical trial enrolling women who suffer from inguinal or femoral hernia, to evaluate if TEP approach is superior to TAPP concerning postoperative development, principally...
Detailed Description
Randomised phase IV clinical trial enrolling women suffering from inguinal hernia in Virgen del Rocío University Hospital influence area, from March 2019 to March 2021. The aim of the study is to con...
Eligibility Criteria
Inclusion
- Inguinofemoral hernia, EHS (European Hernia Society) classification.
- Patient over 18 years old.
- Signed informed consent form.
- Female
- Meeting of outpatient discharge criteria, determined by Aldrete´s test
Exclusion
- Loss of domain.
- Abdominal skin grafts.
- Previous preperitoneal (open or laparoscopic) prosthetic mesh.
- Incarcerated hernia.
- Previous complications such as infection, fistulae…
- Not candidate for ambulatory surgery
- Pregnancy or desire for pregnancy in the first postoperative year
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2023
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04114344
Start Date
May 1 2019
End Date
May 1 2023
Last Update
July 27 2022
Active Locations (1)
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1
Virgen del Rocío University Hospital
Seville, Spain, 41013