Preoperative Diet Before Sleeve Gastrectomy

Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02401399
• Other study ID #: HGUE15-2
• Status: Completed
• Phase: Phase 3
• First received: March 24, 2015
• Last updated: March 24, 2015
• Start date: January 2014
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: Hospital General Universitario Elche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Elche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain		24 hours after surgery	No
Secondary	C reactive protein		24 hours after surgery	No