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

Inguinal Hernia Clinical Trial

— WOLAP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04114344
• Other study ID #: WO_LAP
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: May 2023

Study information

• Verified date: July 2022
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 78
• Est. completion date: May 2023
• Est. primary completion date: October 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Procedure:
• TAPP
Trans Abdominal Pre Peritoneal approach
• TEP
Total Extra Peritoneal approach

Locations

Country	Name	City	State
Spain	Virgen del Rocío University Hospital	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative pain	Post operative pain, measured with Visual Analogue Scale (VAS) (from 0 to 10 points) World Health Organization (WHO)	24 hours
Primary	Recurrence	Recurrence of inguinal hernia in the one-year follow-up	One year
Primary	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	Operating time	Operating time from first incision to closure	180 minutes
Secondary	Hospital stay	length of hospital stay will be measured in hours between the end of the surgery and the time of discharge.	24 hours