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

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status: Active, not recruiting

Conditions: Inguinal Hernia

Treatments: Procedure: TAPP; Procedure: TEP

Study type: Interventional

Funder types: Other

Identifiers

NCT04114344

WO_LAP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

78 participants in 2 patient groups

TAPP (Trans Abdominal PrePeritoneal)

Active Comparator group

Description:

Trans Abdominal PrePeritoneal approach to inguinal hernia repair

Treatment:

Procedure: TAPP

TEP (Totally Extra Peritoneal)

Experimental group

Description:

Totally Extra Peritoneal approach to inguinal hernia repair

Treatment:

Procedure: TEP