Randomized Clinical Trial to Compare TAPP vs TEP Approach for Women's Inguinal Hernia on an Outpatient Basis
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Recurrence
Study Overview
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 postoperative pain, with no increase of recurrent hernia at the one-year follow-up visit.
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 conclusively stablish whether there is real and significant benefit in using TEP approach over TAPP, in an outpatient basis, concerning postoperative evolution. Secondary objectives are the assessment of postoperative pain, using VAS (visual analogic scale), of both techniques, and evaluation of hernia recurrence during the first postoperative year The individuals will be assigned to each group according to simple random sampling.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Inguinofemoral hernia, EHS (European Hernia Society) classification.
- •Patient over 18 years old.
- •Signed informed consent form.
- •Meeting of outpatient discharge criteria, determined by Aldrete´s test
Exclusion Criteria
- •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
Arms & Interventions
TEP (Totally Extra Peritoneal)
Totally Extra Peritoneal approach to inguinal hernia repair
Intervention: TEP (Procedure)
TAPP (Trans Abdominal PrePeritoneal)
Trans Abdominal PrePeritoneal approach to inguinal hernia repair
Intervention: TAPP (Procedure)
Outcomes
Primary Outcomes
Recurrence
Time Frame: One year
Recurrence of inguinal hernia in the one-year follow-up
Post operative pain
Time Frame: 24 hours
Post operative pain, measured with Visual Analogue Scale (VAS) (from 0 to 10 points) World Health Organization (WHO)
Complications
Time Frame: One year
Postoperative complications including wound complications (seroma, haematoma, infection), gastrointestinal complications (ileus, fistula), urological complications (acute retention, haematuria) and hernia complications (recurrence, chronic groin pain) will be reported. Occurrence of major complications will be registered, including intestinal injury, major vascular lesion, bleeding over 500cc and peritonitis.
Secondary Outcomes
- Operating time(180 minutes)
- Hospital stay(24 hours)
Investigators
José Tinoco González
Principal Investigator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla