Preoperative Diet Before Sleeve Gastrectomy

NCT ID: NCT02401399

Last Updated: 2015-03-27

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-02-28

Brief Summary

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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.

Detailed Description

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Patients undergoing sleeve gastrectomy as bariatric procedure ara randomized into 3 groups: those patients receiving a preoperative regular diet of 900 Kcal/day (Group 1), those receiving preoperative balanced energy high protein formula (Group 2) and those receiving preoperative Immunonutrition formula (Group 3). Postoperative pain and acute phase reactants at 24hours after surgery are investigated.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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regular diet

The patients receive regular diet of 900 Kcal/day during 15 days before surgery

Group Type PLACEBO_COMPARATOR

Regular diet

Intervention Type DIETARY_SUPPLEMENT

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

Group Type ACTIVE_COMPARATOR

High protein formula

Intervention Type DIETARY_SUPPLEMENT

The patients receive high protein formula during 15 days before surgery

Immunonutrition

The patients receive Immunonutrition during 15 days before surgery

Group Type EXPERIMENTAL

Immunonutrition

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

High protein formula

The patients receive high protein formula during 15 days before surgery

Intervention Type DIETARY_SUPPLEMENT

Immunonutrition

The patients receive Immunonutrition formula during 15 days before surgery

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* BMI \>40 Kg/m2
* BMI \> 35 Kg/m2 with the presence of comorbidities associated to obesity

Exclusion Criteria

* gastroesophageal reflux
* patients with uncontrolled psychiatric disorders
* active infections or malignancies
* other concomitant pathology considered as a contraindication for bariatric surgery
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital General Universitario Elche

OTHER

Sponsor Role lead

Responsible Party

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Jaime Ruiz-Tovar, MD, PhD

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

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.

Reference Type DERIVED
PMID: 26358120 (View on PubMed)

Other Identifiers

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HGUE15-2

Identifier Type: -

Identifier Source: org_study_id

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