Clinical Trial to Compare TAPP (Transabdominal Preperitoneal) vs TEP (Totally Extraperitoneal) y Approach for Women's Inguinal Hernia on an Outpatient Basis

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla78 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Inguinal Hernia

Interventions

TAPPPROCEDURE

Trans Abdominal Pre Peritoneal approach

TEPPROCEDURE

Total Extra Peritoneal approach

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 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

Locations (1)

Virgen del Rocío University Hospital

Seville, Spain

Outcomes

Primary Outcomes

Post operative pain

Post operative pain, measured with Visual Analogue Scale (VAS) (from 0 to 10 points) World Health Organization (WHO)

Time frame: 24 hours

Recurrence

Recurrence of inguinal hernia in the one-year follow-up

Time frame: One year

Complications

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.

Time frame: One year

Secondary Outcomes

Operating time

Operating time from first incision to closure

Time frame: 180 minutes

Hospital stay

length of hospital stay will be measured in hours between the end of the surgery and the time of discharge.

Time frame: 24 hours

Data from ClinicalTrials.gov

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