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

Not Applicable

• Conditions: Inguinal Hernia

• Registration Number: NCT04114344
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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.

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 Timeline

• Study Start: 2019-05-01
• Study First Submitted: 2019-09-12
• Study First Submitted QC: 2019-10-01
• Study First Posted: 2019-10-03
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-26
• Last Update Posted: 2022-07-27
• Primary Completion: 2022-10
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 78

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recurrence	One year	Recurrence of inguinal hernia in the one-year follow-up
Post operative pain	24 hours	Post operative pain, measured with Visual Analogue Scale (VAS) (from 0 to 10 points) World Health Organization (WHO)
Complications	One year	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Virgen del Rocío University Hospital; 🇪🇸 Sevilla, Spain