Preoperative Diet Before Sleeve Gastrectomy
Preoperative Regular Diet of 900 Kcal/Day vs Balanced Energy High Protein Formula vs Immunonutrition Formula: Effect on Postoperative Pain After Laparoscopic Sleeve Gastrectomy
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
Patients undergoing sleeve gastrectomy aara randomized into 3 groups:preoperative regular diet , preoperative balanced energy high protein formula and Immunonutrition formula.Postoperative pain and acute phase reactants at 24hours after surgery are investigated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 pain
Started Jan 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 24, 2015
CompletedFirst Posted
Study publicly available on registry
March 27, 2015
CompletedMarch 27, 2015
March 1, 2015
1.1 years
March 24, 2015
March 24, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative pain
24 hours after surgery
Secondary Outcomes (1)
C reactive protein
24 hours after surgery
Study Arms (3)
regular diet
PLACEBO COMPARATORThe patients receive regular diet of 900 Kcal/day during 15 days before surgery
high protein formula
ACTIVE COMPARATORThe patients receive high protein formula during 15 days before surgery
Immunonutrition
EXPERIMENTALThe patients receive Immunonutrition during 15 days before surgery
Interventions
The patients receive regular diet 900 Kcal/day during 15 days before surgery
The patients receive high protein formula during 15 days before surgery
The patients receive Immunonutrition formula during 15 days before surgery
Eligibility Criteria
You may qualify if:
- BMI \>40 Kg/m2
- BMI \> 35 Kg/m2 with the presence of comorbidities associated to obesity
You may not qualify if:
- gastroesophageal reflux
- patients with uncontrolled psychiatric disorders
- active infections or malignancies
- other concomitant pathology considered as a contraindication for bariatric surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 26358120DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jaime Ruiz Tovar
Hospital General Elche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
March 24, 2015
First Posted
March 27, 2015
Study Start
January 1, 2014
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
March 27, 2015
Record last verified: 2015-03