Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
60 participants
INTERVENTIONAL
2014-01-31
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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regular diet
The patients receive regular diet of 900 Kcal/day during 15 days before surgery
Regular diet
The patients receive regular diet 900 Kcal/day during 15 days before surgery
high protein formula
The patients receive high protein formula during 15 days before surgery
High protein formula
The patients receive high protein formula during 15 days before surgery
Immunonutrition
The patients receive Immunonutrition during 15 days before surgery
Immunonutrition
The patients receive Immunonutrition formula during 15 days before surgery
Interventions
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Regular diet
The patients receive regular diet 900 Kcal/day during 15 days before surgery
High protein formula
The patients receive high protein formula during 15 days before surgery
Immunonutrition
The patients receive Immunonutrition formula during 15 days before surgery
Eligibility Criteria
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Inclusion Criteria
* BMI \> 35 Kg/m2 with the presence of comorbidities associated to obesity
Exclusion Criteria
* patients with uncontrolled psychiatric disorders
* active infections or malignancies
* other concomitant pathology considered as a contraindication for bariatric surgery
ALL
No
Sponsors
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Hospital General Universitario Elche
OTHER
Responsible Party
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Jaime Ruiz-Tovar, MD, PhD
MD, PhD
Principal Investigators
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Jaime Ruiz Tovar
Role: PRINCIPAL_INVESTIGATOR
Hospital General Elche
References
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Ruiz-Tovar J, Zubiaga L, Diez M, Murcia A, Boix E, Munoz JL, Llavero C; OBELCHE group. Preoperative Regular Diet of 900 kcal/day vs Balanced Energy High-Protein Formula vs Immunonutrition Formula: Effect on Preoperative Weight Loss and Postoperative Pain, Complications and Analytical Acute Phase Reactants After Laparoscopic Sleeve Gastrectomy. Obes Surg. 2016 Jun;26(6):1221-7. doi: 10.1007/s11695-015-1880-7.
Other Identifiers
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HGUE15-2
Identifier Type: -
Identifier Source: org_study_id
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