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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04114344

Acronym

WOLAP

Enrollment

Registered

2019-10-03

Start date

2019-05-01

Completion date

2023-05-31

Last updated

2022-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia

Keywords

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

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.

Interventions

PROCEDURETAPP

Trans Abdominal Pre Peritoneal approach

PROCEDURETEP

Total Extra Peritoneal approach

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Measure	Time frame	Description
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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026