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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02360176 |
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Date of registration:
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05/02/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Benefit of Single Port-surgery in Sleeve Gastrectomy
MINIOB |
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Scientific title:
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Evaluation of Minimally Invasive Bariatric Surgery Using a Single Laparoscopic Trocar (Single Incision of 2.5 to 3 cm) Versus 4 to 7 Trocars in Sleeve Gastrectomy |
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Date of first enrolment:
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January 4, 2017 |
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Target sample size:
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332 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02360176 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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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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Guillaume Pourcher, 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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Montsouris Institut |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- BMI> 35 kg/m2 with comorbidity (s) or> 40 kg/m2
- Patients aged 18 to 65 years
- Discussion and decision sleeve gastrectomy multidisciplinary meeting
- Free, informed and written consent
- Affiliation to a social security or other assurance
Exclusion Criteria - Anesthetics
Exclusion Criteria:
- Uncontrolled severe infection
- Liver disease other than obesity pathology
- Pregnancy (positive hCG)
- Large hiatal hernia
- Esophagitis uncontrolled
- History of gastric bypass and gastric surgery other than gastric banding
- Saving Justice guardianship
- Participation in another ongoing study
- Cognitive or severe mental illness
- Severe and non-stabilized eating disorders
- Addiction to alcohol and psychoactive substances"
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Surgical Treatment of Obesity
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Intervention(s)
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Procedure: Sleeve gastrectomy multi trocar
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Procedure: Sleeve gastrectomy single port
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Primary Outcome(s)
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Complication rate
[Time Frame: up to 24 months]
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Secondary Outcome(s)
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Reduction of excess weight by measuring BMI in kg / m2 pre-and postoperatively
[Time Frame: up 3, 6, 12 and 24 months]
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Complication rate
[Time Frame: up 3, 6, 9, and 12 months]
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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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