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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COMPLETED
NA
143 participants
INTERVENTIONAL
2015-03-31
2016-10-31
Brief Summary
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Detailed Description
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Secondary endpoints: recurrence rate, post-operative complications (short and long-term), foreign body sensation, incidence of surgical-site injury, costs, hospital stay, surgery duration, safety and patients satisfaction.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ProGrip Mesh Repair
80 patients are randomized to inguinal hernia repair using selfgripping ProGrip Mesh (Covidien Parietex ProGrip Self-Fixating Mesh) - sutureless fixation.
Covidien Parietex ProGrip Self-Fixating Mesh
Lichtenstein Operation
80 patients are randomized to inguinal hernia repair using lightweight polypropylene mesh (\<40 g/m2) with standard Lichtenstein technique.
Lightweight Polypropylene Mesh (<38g/m2 after absorption)
Serag Wiessner SERAMESH® PA 15x10 cm
Interventions
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Covidien Parietex ProGrip Self-Fixating Mesh
Lightweight Polypropylene Mesh (<38g/m2 after absorption)
Serag Wiessner SERAMESH® PA 15x10 cm
Eligibility Criteria
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Inclusion Criteria
* Signed consent
Exclusion Criteria
* Emergency procedure
* Patient not willing to participate
18 Years
ALL
No
Sponsors
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Medical University of Gdansk
OTHER
Regional Health Center in Kartuzy, Poland
OTHER
Responsible Party
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Principal Investigators
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Mateusz T Zamkowski, MD
Role: STUDY_CHAIR
Regional Health Center in Kartuzy, Department of General Surgery
Locations
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Regional Health Center in Kartuzy
Kartuzy, , Poland
Countries
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References
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Sanders DL, Nienhuijs S, Ziprin P, Miserez M, Gingell-Littlejohn M, Smeds S. Randomized clinical trial comparing self-gripping mesh with suture fixation of lightweight polypropylene mesh in open inguinal hernia repair. Br J Surg. 2014 Oct;101(11):1373-82; discussion 1382. doi: 10.1002/bjs.9598. Epub 2014 Aug 21.
Other Identifiers
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NKBNN/258/2015
Identifier Type: -
Identifier Source: org_study_id
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