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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
NCT02748629 |
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Date of registration:
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12/04/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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ProGrip Mesh Repair vs Lichtenstein Operation
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Scientific title:
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Randomized Controlled Single-Center Trial: Self-Gripping ProGrip Mesh Repair vs Lichtenstein Operation of Inguinal Hernia |
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Date of first enrolment:
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March 2015 |
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Target sample size:
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143 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02748629 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Poland
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Contacts
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Name:
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Mateusz T Zamkowski, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Regional Health Center in Kartuzy, Department of General Surgery |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All patients with primary inguinal hernia
- Signed consent
Exclusion Criteria:
- Recurrent hernia
- Emergency procedure
- Patient not willing to participate
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Inguinal Hernia
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Intervention(s)
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Device: Covidien Parietex ProGrip Self-Fixating Mesh
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Device: Lightweight Polypropylene Mesh (<38g/m2 after absorption)
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Primary Outcome(s)
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Incidence of post-operative pain and its intensity using VAS Scale
[Time Frame: 12 Months]
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Secondary Outcome(s)
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Hernia recurrence rate
[Time Frame: 12 Months]
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Incidence of Treatment-Emergent Adverse Events [Safety]
[Time Frame: 12 Months]
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Duration of surgery
[Time Frame: Day of surgery]
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Post-operative complications
[Time Frame: 12 Months]
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Rate of foreign body sensation - Subjective feeling of discomfort in the groin
[Time Frame: 12 Months]
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Secondary ID(s)
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NKBNN/258/2015
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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