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OpenTrials
Completed

NCT Number: NCT02401399

Preoperative Diet Before Sleeve Gastrectomy

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Regular diet

Dietary Supplement

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

High protein formula

Dietary Supplement

The patients receive high protein formula during 15 days before surgery

Immunonutrition

Dietary Supplement

The patients receive Immunonutrition formula during 15 days before surgery

Primary outcomes

  1. Postoperative pain

    Time frame: 24 hours after surgery

Secondary outcomes

  1. C reactive protein

    Time frame: 24 hours after surgery

Sponsors and collaborators

Lead sponsor

Hospital General Universitario Elche

Other

Registry information

Official study title

Preoperative Regular Diet of 900 Kcal/Day vs Balanced Energy High Protein Formula vs Immunonutrition Formula: Effect on Postoperative Pain After Laparoscopic Sleeve Gastrectomy

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 27, 2015
Registry last updated
Mar 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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