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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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14 January 2013 |
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Main ID: |
NCT01063959 |
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Date of registration:
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04/02/2010 |
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Primary sponsor: |
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Public title:
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Sleeve Gastrectomy Versus Gastric Bypass for Private Pay Patients Seeking Obesity Surgery
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Scientific title:
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Advantages of Sleeve Gastrectomy Over Gastric Bypass for Private Pay Patients Seeking Obesity Surgery |
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Date of first enrolment:
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February 2010 |
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Target sample size:
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1600 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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http://clinicaltrials.gov/show/NCT01063959 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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Countries of recruitment
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United States
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Contacts
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Name:
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Drake Bellanger, 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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Pennington Biomedial Research Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- The last 800 consecutive patients in the surgical practice of Drake Bellanger and
Andrew Hargroder who had a laparoscopic sleeve gastrectomy.
- The last 800 consecutive patients in the surgical practice of Drake Bellanger and
Andrew Hargroder who had a laparoscopic gastric bypass.
Exclusion Criteria:
- Subjects having any other obesity surgical procedure
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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Morbid Obesity
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Intervention(s)
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Procedure: Laparoscopic Gastric Bypass
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Procedure: Laparoscopic Sleeve Gastrectomy
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Primary Outcome(s)
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Comparison of the incidence of weight loss and complications operatively and in the first 6 weeks post-operatively after gastric bypass compared to sleeve gastrectomy.
[Time Frame: 18 Months]
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Secondary Outcome(s)
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Comparison of the incidence of complications in gastric bypass patients covered by insurance vs. private pay patients during surgery, in the hospital and during the first 6 weeks post-operatively.
[Time Frame: 18 Months]
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Secondary ID(s)
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FWA 00006218
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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