Preoperative Diet Before Sleeve Gastrectomy

Phase 3

Completed

• Conditions: Pain

• Registration Number: NCT02401399
• Lead Sponsor: Hospital General Universitario Elche

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-03
• Study First Submitted: 2015-03-24
• Study First Submitted QC: 2015-03-24
• Last Update Submitted: 2015-03-24
• Study First Posted: 2015-03-27
• Last Update Posted: 2015-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative pain	24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
C reactive protein	24 hours after surgery