Clinical Trial to Compare TAPP (Transabdominal Preperitoneal) vs TEP (Totally Extraperitoneal) y Approach for Women's Inguinal Hernia on an Outpatient Basis
NCT ID: NCT04114344
Last Updated: 2022-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
78 participants
INTERVENTIONAL
2019-05-01
2023-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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TAPP (Trans Abdominal PrePeritoneal)
Trans Abdominal PrePeritoneal approach to inguinal hernia repair
TAPP
Trans Abdominal Pre Peritoneal approach
TEP (Totally Extra Peritoneal)
Totally Extra Peritoneal approach to inguinal hernia repair
TEP
Total Extra Peritoneal approach
Interventions
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TAPP
Trans Abdominal Pre Peritoneal approach
TEP
Total Extra Peritoneal approach
Eligibility Criteria
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Inclusion Criteria
* Patient over 18 years old.
* Signed informed consent form.
* Female
* Meeting of outpatient discharge criteria, determined by Aldrete´s test
Exclusion Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
OTHER
Responsible Party
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José Tinoco González
Principal Investigator
Locations
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Virgen del Rocío University Hospital
Seville, , Spain
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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WO_LAP
Identifier Type: -
Identifier Source: org_study_id
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