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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT01015157 |
Date of registration:
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05/08/2009 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Prospective Trial Using Gastric Stapling Line Reinforcement With Seamguard in Roux-en-Y Gastric Bypass
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Scientific title:
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Laparoscopic Roux-en-Y Gastric Bypass Outcomes With Systematic Gastric Stapling Line Reinforcement With Seamguard Biomaterial |
Date of first enrolment:
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July 2009 |
Target sample size:
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80 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT01015157 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Philippe A Topart, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Société de Chirurgie Viscérale |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- all primary laparoscopic Roux-en-Y gastric bypasses for morbid obesity
Exclusion Criteria:
- additional procedures except cholecystectomy, peroperative bleeding from spleen or
liver injury
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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Gastric Bypass
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Intervention(s)
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Procedure: Roux-en-Y laparoscopic gastric bypass for morbid obesity
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Primary Outcome(s)
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Blood loss volume per and postoperatively, additional hemostatic measures peroperatively, hemoglobin levels postoperatively
[Time Frame: 3 days postoperatively]
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Secondary Outcome(s)
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gastrojejunal anastomosis leakage rate: clinical and radiological
[Time Frame: postoperative day 2 (gastrograffin swallow)]
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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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