Study on Ultrapro vs Polypropylene: Early Results From a Multicentric Experience in Surgery for Hernia
NCT ID: NCT02666040
Last Updated: 2016-01-28
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
1200 participants
INTERVENTIONAL
2009-11-30
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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U - ULTRAPRO
Inguinal Hernia Surgery with ULTRAPRO® meshes, a new ULTRAPRO® mesh will be implanted in patients in the group (AG). The surgery will be evaluated in terms of procedure, detecting the mode of admission to hospital, the duration of surgery, anesthesia volume and type used, composition of the surgical equipment.
ULTRAPRO® meshes
The inguinal hernia repair has to be performed with the Lichtenstein technique, with standardized prosthesis fixation and no use of plug.
Detecting the mode of admission to hospital
Ordinary admission or day surgery
Duration of surgery
Time operating room
Anesthesia volume and type used
Anesthesias used: infiltration, followed by spinal, general, epidural.
P - Prolene
Inguinal Hernia Surgery with "Prolene®" meshes, the conventional mesh in polypropylene "Prolene®" will be implanted in patients in the control group (CG). The surgery will be evaluated in terms of procedure, detecting the mode of admission to hospital, the duration of surgery, anesthesia volume and type used, composition of the surgical equipment.
"Prolene®" meshes
The inguinal hernia repair has to be performed with the Lichtenstein technique, with standardized prosthesis fixation and no use of plug.
Detecting the mode of admission to hospital
Ordinary admission or day surgery
Duration of surgery
Time operating room
Anesthesia volume and type used
Anesthesias used: infiltration, followed by spinal, general, epidural.
Interventions
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ULTRAPRO® meshes
The inguinal hernia repair has to be performed with the Lichtenstein technique, with standardized prosthesis fixation and no use of plug.
"Prolene®" meshes
The inguinal hernia repair has to be performed with the Lichtenstein technique, with standardized prosthesis fixation and no use of plug.
Detecting the mode of admission to hospital
Ordinary admission or day surgery
Duration of surgery
Time operating room
Anesthesia volume and type used
Anesthesias used: infiltration, followed by spinal, general, epidural.
Eligibility Criteria
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Inclusion Criteria
* Males and females
* Adults over 18
* All primitive inguinal hernia
Exclusion Criteria
* Impossibility to complete the follow-up
* Patients with acquired immunodeficiency symptoms
* Patients with relapsed inguinal hernia
18 Years
ALL
No
Sponsors
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Zeta Research Ltd
INDUSTRY
Istituto Clinico Humanitas
OTHER
Responsible Party
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Michele Tedeschi
Clinical Research Coordinator
Principal Investigators
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Marco Montorsi, Prof.
Role: PRINCIPAL_INVESTIGATOR
Humanitas Research Hospital IRCCS, Rozzano-Milan
Other Identifiers
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10-v035
Identifier Type: -
Identifier Source: org_study_id
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