NCT03010280

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2017

Completed
Last Updated

February 14, 2018

Status Verified

August 1, 2017

Enrollment Period

7 months

First QC Date

January 3, 2017

Last Update Submit

February 12, 2018

Conditions

Postoperative Complications

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Decrease in systemic inflamatory response in terms of other inflamatory biomarkers

    24 hours after surgery

  • Postoperative pain

    24h after surgery

  • Complications

    30 days after surgery

  • In-hospital stay

    30 days after surgery

  • Number of readmissions

    30 days after surgery

  • +1 more secondary outcomes

Study Arms (2)

Immunonutrition

EXPERIMENTAL

Patients receiving a preoperative balanced energy high-protein formula, enriched with Omega - 3 fatty acids (Immunonutrition formula)

Dietary Supplement: Immunonutrition

Balanced high-protein formula

ACTIVE COMPARATOR

Patients receiving a preoperative balanced energy high-protein formula, without including Omega - 3 fatty acids

Dietary Supplement: Balanced high-protein formula

Interventions

ImmunonutritionDIETARY_SUPPLEMENT

Balanced high-protein formula enriched with Omega-3 fatty acids. 200 ml of formula every 8 hours during 10 days preoperatively

Immunonutrition
Balanced high-protein formulaDIETARY_SUPPLEMENT

Balanced high-protein formula, without Omega-3 fatty acids. 200 ml of formula every 8 hours during 10 days preoperatively

Balanced high-protein formula

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundacion Jimenez Diaz

Madrid, Spain

Location

Related Publications (1)

  • 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.

    PMID: 30097364DERIVED

MeSH Terms

Conditions

Postoperative Complications

Interventions

Immunonutrition Diet

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Jaime Ruiz-Tovar

    Fundacion Jimenez Diaz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2017

First Posted

January 5, 2017

Study Start

February 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

February 14, 2018

Record last verified: 2017-08

Locations

ES(1)