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

NCT ID: NCT04114344

Last Updated: 2022-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2023-05-31

Brief Summary

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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

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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.

Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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TAPP (Trans Abdominal PrePeritoneal)

Trans Abdominal PrePeritoneal approach to inguinal hernia repair

Group Type ACTIVE_COMPARATOR

TAPP

Intervention Type PROCEDURE

Trans Abdominal Pre Peritoneal approach

TEP (Totally Extra Peritoneal)

Totally Extra Peritoneal approach to inguinal hernia repair

Group Type EXPERIMENTAL

TEP

Intervention Type PROCEDURE

Total Extra Peritoneal approach

Interventions

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TAPP

Trans Abdominal Pre Peritoneal approach

Intervention Type PROCEDURE

TEP

Total Extra Peritoneal approach

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role lead

Responsible Party

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José Tinoco González

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Virgen del Rocío University Hospital

Seville, , Spain

Site Status

Countries

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Spain

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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WO_LAP

Identifier Type: -

Identifier Source: org_study_id

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