Preoperative Diet Before Sleeve Gastrectomy

Hospital General Universitario Elche

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Dietary Supplement: High protein formula; Dietary Supplement: Regular diet; Dietary Supplement: Immunonutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT02401399

HGUE15-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 3 patient groups, including a placebo group

regular diet

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Regular diet

high protein formula

Active Comparator group

Description:

The patients receive high protein formula during 15 days before surgery

Treatment:

Dietary Supplement: High protein formula

Immunonutrition

Experimental group

Description:

The patients receive Immunonutrition during 15 days before surgery

Treatment:

Dietary Supplement: Immunonutrition