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

NCT04114344 | Unknown DMC

• 1 other identifier: WO_LAP
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernia

Keywords

Woman; Inguinal Hernia; TAPP; TEP; Outpatient Surgery; Ambulatory Surgery

Outcome Measures

Primary Outcomes (3)

• Post operative pain

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

  24 hours

• Recurrence

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

  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.

  One year

Secondary Outcomes (2)

• Operating time

  180 minutes

• Hospital stay

  24 hours

Study Arms (2)

TAPP (Trans Abdominal PrePeritoneal)

ACTIVE COMPARATOR

Trans Abdominal PrePeritoneal approach to inguinal hernia repair

Procedure: TAPP

TEP (Totally Extra Peritoneal)

EXPERIMENTAL

Totally Extra Peritoneal approach to inguinal hernia repair

Procedure: TEP

Interventions

TAPP PROCEDURE

Trans Abdominal Pre Peritoneal approach

TAPP (Trans Abdominal PrePeritoneal)

TEP PROCEDURE

Total Extra Peritoneal approach

TEP (Totally Extra Peritoneal)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (1)

Virgen del Rocío University Hospital

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

tetra-4-amidinophenoxypropane; tetraethylpyrazine

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: October 3, 2019
• Study Start: May 1, 2019
• Primary Completion: October 1, 2022
• Study Completion: May 1, 2023
• Last Updated: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)