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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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12 December 2020 |
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Main ID: |
NCT01534780 |
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Date of registration:
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09/02/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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3 Fixation Devices in Laparoscopic Ventral Herniotomy
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Scientific title:
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A Controlled Randomized Study of Protack, Securestrap and Glubran Glue as Fixation Devices in Laparoscopic Ventral Herniotomy |
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Date of first enrolment:
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April 2013 |
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Target sample size:
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75 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01534780 |
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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: Factorial Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Sanne S Harsløf, 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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Horsens Regional Hospital |
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Name:
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Thorbjørn Sommer, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Randers Regional Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- ventral hernia 2(1,5) < dia > 7 cm
- danish speaking
- of sound mind
- bmi < 35
- ASA 3 or less, no contra indication against laparoscopy
Exclusion Criteria:
- other size hernias,
- no danish,
- bmi > 35
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ventral Hernia
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Intervention(s)
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Device: Glubran
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Device: Securestrap
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Procedure: laparoscopic ventral herniotomy
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Device: Protack
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Primary Outcome(s)
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Pain
[Time Frame: 1 measurement, 2nd postoperative day]
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Secondary Outcome(s)
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Pain
[Time Frame: 7 measurements, day 1, 3 and 4 and postoperative month 1, 6, 12, 24]
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hernia recurrence
[Time Frame: 7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60]
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quality of life
[Time Frame: 7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60]
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Secondary ID(s)
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KIR-001-HRH
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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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