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Main
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Note: This record shows only the 20 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 2012 |
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Main ID: |
NCT01170780 |
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Date of registration:
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26/07/2010 |
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Primary sponsor: |
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Public title:
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Dexamethasone Versus Placebo in Optimizing the Postoperative Period After Laparoscopic Inguinal Hernia Repair
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Scientific title:
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Dexamethasone Versus Placebo in Optimizing the Postoperative Period After Laparoscopic Inguinal Hernia Repair |
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Date of first enrolment:
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August 2010 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01170780 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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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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Mette A Tolver, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Koege |
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Name:
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Thue Bisgaard, M.D. DMSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Koege |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patients planned for elective laparoscopic hernia repair (TAPP)
- Unilateral inguinal or femoral hernia
- ASA class I-II
- Read and speak Danish
Exclusion Criteria:
- Acute hernia operation
- Operation for other hernias with mesh during the same procedure
- Endocrine disease (diabetes, adrenal insufficiency etc.)
- fever/infection within the first 10 days before operation
- Poor compliance
- No signed consent form
- Daily intake of opioids or anxiolytic drugs
- Manic episodes
- Use medicine against glaucoma
- Use thiazide or loop diuretics
- Vaccination within the last 14 days
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Femoral Hernia
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Inguinal Hernia
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Intervention(s)
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Drug: Dexamethasone
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Drug: Saline
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Primary Outcome(s)
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pain during coughing
[Time Frame: day 1]
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Secondary Outcome(s)
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convalescence
[Time Frame: 1 month]
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discomfort
[Time Frame: 4 days]
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fatigue
[Time Frame: 4 days]
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nausea
[Time Frame: 2 days]
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pain at rest
[Time Frame: 4 days]
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pain during coughing
[Time Frame: 4 days]
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vomiting
[Time Frame: 2 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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