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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: |
NCT01420757 |
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Date of registration:
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18/08/2011 |
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Primary sponsor: |
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Public title:
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Laparoscopic Versus Open Incisional Hernia Repair
COLIBRI |
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Scientific title:
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Laparoscopic Versus Open Incisional Hernia Repair : A Randomized Clinical Trial |
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Date of first enrolment:
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May 1999 |
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Target sample size:
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206 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01420757 |
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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: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Contacts
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Name:
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J.F. Lange, 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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Erasmus Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- hernia diameter between 3 and 15 cm
- location at the ventral abdominal wall at least 5cm from costae and inguinal area
- indication for elective repair
- age of 18 years or older
- written informed consent.
Exclusion Criteria:
- contraindication for pneumoperitoneum
- an absolute contraindication for general anesthesia
- history of open abdomen treatment
- patients participating in other trials
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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Complications
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Postoperative Pain
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Recurrence
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Intervention(s)
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Procedure: incisional hernia repair
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Primary Outcome(s)
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Postoperative pain
[Time Frame: 4 weeks]
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Secondary Outcome(s)
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complications
[Time Frame: 4 weeks]
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length of hospital stay
[Time Frame: 4 weeks]
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mortality
[Time Frame: 5 years]
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operation time
[Time Frame: 1 day]
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Postoperative analgesics use
[Time Frame: 1 week]
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recurrence
[Time Frame: 5 years]
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Secondary ID(s)
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COLIBRI trial
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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