Clinical trial NCT03010280: Effect of Immunonutrition on Inflamatory Markers After Bariatric Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Complications
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Rey Juan Carlos
First posted: 2017-01-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Decrease in systemic inflamatory response in terms of CRP
timeFrame: 24h after surgery
Secondary outcomes:
measure: Decrease in systemic inflamatory response in terms of other inflamatory biomarkers
timeFrame: 24 hours after surgery
measure: Postoperative pain
timeFrame: 24h after surgery
measure: Complications
timeFrame: 30 days after surgery
measure: In-hospital stay
timeFrame: 30 days after surgery
measure: Number of readmissions
timeFrame: 30 days after surgery
measure: Adverse Events Ocurrence
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
Study officials:
affiliation: Fundacion Jimenez Diaz
name: Jaime Ruiz-Tovar
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruiz-Tovar J, Blanca M, Garcia A, Gonzalez J, Gutierrez S, Paniagua A, Prieto MJ, Ramallo L, Llanos L, Duran M. Preoperative administration of Omega-3 fatty acids on postoperative pain and acute-phase reactants in patients undergoing Roux-en-Y gastric bypass: A randomized clinical trial. Clin Nutr. 2019 Aug;38(4):1588-1593. doi: 10.1016/j.clnu.2018.07.026. Epub 2018 Jul 29.