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

Randomized Clinical Trial to Compare TAPP vs TEP Approach for Women's Inguinal Hernia on an Outpatient Basis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Inguinal Hernia
• Intervention / Treatment: Procedure: TAPP; Procedure: TEP

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 Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Sevilla, Spain, 41013
    • Virgen del Rocio University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TAPP (Trans Abdominal PrePeritoneal); Trans Abdominal PrePeritoneal approach to inguinal hernia repair	Procedure: TAPP; Trans Abdominal Pre Peritoneal approach
Experimental: TEP (Totally Extra Peritoneal); Totally Extra Peritoneal approach to inguinal hernia repair	Procedure: TEP; Total Extra Peritoneal approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operating time	Operating time from first incision to closure	180 minutes
Hospital stay	length of hospital stay will be measured in hours between the end of the surgery and the time of discharge.	24 hours

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: TEP; Inguinal Hernia; TAPP; Outpatient Surgery; Woman; Ambulatory Surgery
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: WO_LAP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No