Effect of Immunonutrition on Inflamatory Markers After Bariatric Surgery

Not Applicable

Completed

• Conditions: Postoperative Complications
• Interventions: Dietary Supplement: Balanced high-protein formula; Dietary Supplement: Immunonutrition

• Registration Number: NCT03010280
• Lead Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Brief Summary

A prospective randomized clinical trial of all the patients undergoing Roux - en-Y gastric bypass will be performed. Patients will be randomly assigned into 2 groups: those patients receiving a preoperative balanced energy high-protein formula (group 1) and those receiving preoperative Immunonutrition (group 2). Changes between groups in acute inflamatory markers, pain, postoperative septic complications and lenght of stay, among others will be investigated.

Detailed Description

A prospective randomized clinical trial of all the patients undergoing Roux - en-Y gastric bypass will be performed. Patients will be randomly assigned into 2 groups: those patients receiving a preoperative balanced energy high-protein formula (group 1) and those receiving preoperative Immunonutrition (group 2). Changes between groups in acute inflamatory markers (CRP, fibrinogen, leucocites), pain (VAS scale), postoperative septic complications .(anastomotic leak and organ/space SSI)and lenght of stay, among others will be investigated.

Study Timeline

• Study Start: 2016-02
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-01-03
• Study First Posted: 2017-01-05
• Status Verified: 2017-08
• Last Update Submitted: 2018-02-12
• Last Update Posted: 2018-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients undergoing a laparoscopic gastric bypass (BPG) as a bariatric procedure
2. Men and Women older than 18 years.
3. Willing to participate in the study and giving their written consent

Exclusion Criteria

1. Patients younger than 18 years.
2. Patients undergoing other bariatric surgery techniques.
3. Patients undergoing any other surgical procedure added to the bariatric technique.
4. Patients with medical or surgical pathologies that at the discretion of the investigator do not allow their participation in the study.
5. Inability to understand the nature and purpose of the study and / or to accept written participation in the study.
6. Impossibility to comply with pre-established clinical follow-up.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Balanced high-protein formula	Balanced high-protein formula	Patients receiving a preoperative balanced energy high-protein formula, without including Omega - 3 fatty acids
Immunonutrition	Immunonutrition	Patients receiving a preoperative balanced energy high-protein formula, enriched with Omega - 3 fatty acids (Immunonutrition formula)

Primary Outcome Measures

Name	Time	Method
Decrease in systemic inflamatory response in terms of CRP	24h after surgery	Proportion of patients with at least a 50% decrease in CRP 24 after surgery

Secondary Outcome Measures

Name	Time	Method
Postoperative pain	24h after surgery	Mean VAS score
Decrease in systemic inflamatory response in terms of other inflamatory biomarkers	24 hours after surgery	Mean decrease in leukocite count, fibrinogen
Adverse Events Ocurrence	30 days after surgery	AE rate
Complications	30 days after surgery	Rate of complications
In-hospital stay	30 days after surgery	In-hospital stay
Number of readmissions	30 days after surgery	Number of readmissions

Trial Locations

Locations (1)

Fundacion Jimenez Diaz; 🇪🇸 Madrid, Spain