Effect of Immunonutrition on Inflamatory Markers After Bariatric Surgery

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03010280
• Other study ID #: INMUNOBAR-HURJC-15/01
• Status: Completed
• Phase: N/A
• First received: January 3, 2017
• Last updated: February 12, 2018
• Start date: February 2016
• Est. completion date: September 2016

Study information

• Verified date: August 2017
• Source: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

Dietary Supplement:
• Immunonutrition
Balanced high-protein formula enriched with Omega-3 fatty acids. 200 ml of formula every 8 hours during 10 days preoperatively
• Balanced high-protein formula
Balanced high-protein formula, without Omega-3 fatty acids. 200 ml of formula every 8 hours during 10 days preoperatively

Locations

Country	Name	City	State
Spain	Fundacion Jimenez Diaz	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz	Hospital Universitario Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in systemic inflamatory response in terms of CRP	Proportion of patients with at least a 50% decrease in CRP 24 after surgery	24h after surgery
Secondary	Decrease in systemic inflamatory response in terms of other inflamatory biomarkers	Mean decrease in leukocite count, fibrinogen	24 hours after surgery
Secondary	Postoperative pain	Mean VAS score	24h after surgery
Secondary	Complications	Rate of complications	30 days after surgery
Secondary	In-hospital stay	In-hospital stay	30 days after surgery
Secondary	Number of readmissions	Number of readmissions	30 days after surgery
Secondary	Adverse Events Ocurrence	AE rate	30 days after surgery