Postoperative ComplicationsNCT03010280
Effect of Immunonutrition on Inflamatory Markers After Bariatric Surgery
A study testing Immunonutrition and Balanced high-protein formula in people with Postoperative Complications, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Immunonutrition and Balanced high-protein formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2016to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Immunonutrition, Balanced high-protein formula
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunonutritionDietary supplement
Balanced high-protein formula enriched with Omega-3 fatty acids. 200 ml of formula every 8 hours during 10 days preoperatively
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
| Study group | Role | What they receive |
|---|---|---|
| Immunonutrition | Experimental | Patients receiving a preoperative balanced energy high-protein formula, enriched with Omega - 3 fatty acids (Immunonutrition formula) Receives: Dietary Supplement: Immunonutrition |
| Balanced high-protein formula | Active comparator | Patients receiving a preoperative balanced energy high-protein formula, without including Omega - 3 fatty acids Receives: Dietary Supplement: Balanced high-protein formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in systemic inflamatory response in terms of CRP
Proportion of patients with at least a 50% decrease in CRP 24 after surgery
Measured: 24h after surgery
Secondary outcomes (6)
Decrease in systemic inflamatory response in terms of other inflamatory biomarkers
Mean decrease in leukocite count, fibrinogen
Measured: 24 hours after surgery
Postoperative pain
Mean VAS score
Measured: 24h after surgery
Complications
Rate of complications
Measured: 30 days after surgery
In-hospital stay
In-hospital stay
Measured: 30 days after surgery
Number of readmissions
Number of readmissions
Measured: 30 days after surgery
Adverse Events Ocurrence
AE rate
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startFeb 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Rey Juan Carlos
- Responsible party
- Sponsor
- Investigators
- Jaime Ruiz-Tovar, Principal investigator, Fundacion Jimenez Diaz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010280
- Sponsor's protocol ID
- INMUNOBAR-HURJC-15/01
- Status last verified
- Aug 2017
- First submitted
- 3 Jan 2017
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30097364
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03010280
- Acronym / sponsor ID
- INMUNOBAR-HURJC-15/01
- Conditions
- Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Collaborators
- Hospital Universitario Rey Juan Carlos
- Study start
- Feb 2016 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunonutrition | Experimental | Dietary Supplement: ImmunonutritionPatients receiving a preoperative balanced energy high-protein formula, enriched with Omega - 3 fatty acids (Immunonutrition formula) |
| Balanced high-protein formula | Active comparator | Dietary Supplement: Balanced high-protein formulaPatients receiving a preoperative balanced energy high-protein formula, without including Omega - 3 fatty acids |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImmunonutritionBalanced high-protein formula enriched with Omega-3 fatty acids. 200 ml of formula every 8 hours during 10 days preoperatively | Dietary supplement | Immunonutrition |
| Balanced high-protein formulaBalanced high-protein formula, without Omega-3 fatty acids. 200 ml of formula every 8 hours during 10 days preoperatively | Dietary supplement | Balanced high-protein formula |
Primary outcome
Decrease in systemic inflamatory response in terms of CRP
Time frame: 24h after surgery
Proportion of patients with at least a 50% decrease in CRP 24 after surgery
6 secondary outcomes
Decrease in systemic inflamatory response in terms of other inflamatory biomarkers
Time frame: 24 hours after surgery
Postoperative pain
Time frame: 24h after surgery
Complications
Time frame: 30 days after surgery
In-hospital stay
Time frame: 30 days after surgery
Number of readmissions
Time frame: 30 days after surgery
Adverse Events Ocurrence
Time frame: 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Derived from this study: PubMed 30097364Ruiz-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaime Ruiz-Tovar principal investigator
Fundacion Jimenez Diaz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunonutrition and Balanced high-protein formula in people with Postoperative Complications, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in systemic inflamatory response in terms of CRP (time frame: 24h after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03010280, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2018.