Postoperative Complications
Conditions
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.
Interventions
DIETARY_SUPPLEMENTImmunonutrition
Balanced high-protein formula enriched with Omega-3 fatty acids. 200 ml of formula every 8 hours during 10 days preoperatively
DIETARY_SUPPLEMENTBalanced high-protein formula
Balanced high-protein formula, without Omega-3 fatty acids. 200 ml of formula every 8 hours during 10 days preoperatively
Sponsors
Hospital Universitario Rey Juan Carlos
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | 24h after surgery | Mean VAS score |
| Complications | 30 days after surgery | Rate of complications |
| Decrease in systemic inflamatory response in terms of other inflamatory biomarkers | 24 hours after surgery | Mean decrease in leukocite count, fibrinogen |
| Number of readmissions | 30 days after surgery | Number of readmissions |
| Adverse Events Ocurrence | 30 days after surgery | AE rate |
| In-hospital stay | 30 days after surgery | In-hospital stay |
Countries
Spain
Outcome results
None listed