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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: |
NCT01387828 |
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Date of registration:
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01/07/2011 |
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Primary sponsor: |
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Public title:
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Comparison Between Open and Laparoscopic Splenic Aneurysms Repair
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Scientific title:
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Prospective Randomized Comparison of Open Versus Laparoscopic Management of Splenic Artery Aneurysms. A Ten-Year Study |
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Date of first enrolment:
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January 2001 |
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Target sample size:
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29 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01387828 |
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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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Countries of recruitment
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Italy
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Contacts
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Name:
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Guido AM Tiberio, 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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University of Brescia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Splenic artery aneurysm with diameter greater than 2 cm
- Splenic artery aneurysm with diameter smaller than 2 cm if risk factors for rupture
are associated (child bearing age, pregnancy, blister or saccular shape, increasing
diameter)
Exclusion Criteria:
- Complex aneurysm involving the celiac trunk
- American Society of Anesthesiologists (ASA) Score > 3
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Splenic Artery Aneurysm
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Intervention(s)
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Procedure: Laparoscopic splenic aneurysm repair, eventual splenectomy
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Procedure: Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomy
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Primary Outcome(s)
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Overall postoperative morbidity rate
[Time Frame: During and after hospital stay, an expected average of 50 months]
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Secondary Outcome(s)
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Hospital stay length
[Time Frame: Partcipants will be followed for the duration of hospital stay, an expected average of one week]
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Intra-abdominal surgical drain removal time
[Time Frame: Partcipants will be followed for the duration of hospital stay, an expected average of one week]
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Resumption of oral diet
[Time Frame: Partcipants will be followed for the duration of hospital stay, an expected average of one week]
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Secondary ID(s)
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AOB 01-11
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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