Comparison Between Elliptical Domed Mesh Technique and Lichtenstein Technique in Inguinal Hernia
NCT ID: NCT01348477
Last Updated: 2011-05-05
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
168 participants
INTERVENTIONAL
2010-10-31
2011-12-31
Brief Summary
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Detailed Description
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Group A: 84 patients treated with the new technique Group B: 84 patients treated with the technique of Lichtenstein (gold standard) The investigators reviewed the patients operated on one week, one month, three months and six months after surgery. The investigators evaluated the presence of moderate to severe pain in each technique, as well as the intensity of pain, measured by visual analogue scale.
The investigators also determined the presence of inguinal dysesthesias in each technique, measured by dermatome mapping.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Elliptical domed mesh technique
84 adult patients with primary uncomplicated inguinal hernia, treated with an open preperitoneal elliptical mesh technique
Elliptical domed mesh technique
A segment of polypropylene mesh of 10 by 15cm enters the inguinal preperitoneal space, where takes the form of a dome and is fixed by four stitches
Lichtenstein technique
84 adult patients with primary uncomplicated inguinal hernia treated with the Lichtenstein technique (gold standard)
Elliptical domed mesh technique
A segment of polypropylene mesh of 10 by 15cm enters the inguinal preperitoneal space, where takes the form of a dome and is fixed by four stitches
Interventions
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Elliptical domed mesh technique
A segment of polypropylene mesh of 10 by 15cm enters the inguinal preperitoneal space, where takes the form of a dome and is fixed by four stitches
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* mentally healthy patients
* patients without preoperative groin pain
* patients eligible for outpatient surgery
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Instituto Mexicano del Seguro Social
OTHER_GOV
Responsible Party
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Mexican Social Security Institute
Principal Investigators
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Rafal L Smolinski, surgeon
Role: PRINCIPAL_INVESTIGATOR
IMSS
Martha A Hernandez, researcher
Role: STUDY_DIRECTOR
IMSS
Sergio E Solorio, researcher
Role: STUDY_CHAIR
IMSS
Locations
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Ambulatory care medical unit number 55 (UMAA 55)
León, Guanajuato, Mexico
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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R-2010-1005-10
Identifier Type: -
Identifier Source: org_study_id
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