NCT03010280

Effect of Immunonutrition on Inflamatory Markers After Bariatric Surgery

A Controlled, Randomized, Open Clinical Trial to Compare the Effect of Preoperatory Treatment With Immunonutrition vs Hyperproteic Nutritional Supplements on Postoperative Inflammation Markers in Patients Going Through Bariatric Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Complications

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Immunonutrition	Balanced high-protein formula enriched with Omega-3 fatty acids. 200 ml of formula every 8 hours during 10 days preoperatively
DIETARY_SUPPLEMENT	Balanced high-protein formula	Balanced high-protein formula, without Omega-3 fatty acids. 200 ml of formula every 8 hours during 10 days preoperatively

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2017-01-05
• Last updated: 2018-02-14

Locations

1 site across 1 country: Spain