IMMUNONUTRITIONNCT02393976
IMMUNONUTRITION IN FAST-TRACK SURGERY
A study testing IMMUNONUTRITION and STANDART NUTRITION in people with IMMUNONUTRITION, run by Hospital General Universitario Elche at 1 site in Spain.
Trial summary
Compare the results in terms of morbidity, mortality and hospitalization among patients with input from immunonutrients and patients with enteral nutrition intake of high calorie and high protein undergoing colorectal surgery within a multimodal rehabilitation program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IMMUNONUTRITION
- What is being tested?
- IMMUNONUTRITION and STANDART NUTRITION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2014to Mar 2015
- 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 colorectal surgery.
- Signing informed consent.
Who cannot join
- Patients with no oral nutrition (dysphagia, esophageal stricture, pyloric stenosis)
- Patients with contraindications for electrical stimulation.
- Psychiatric Disorders
- HIV
- Pregnant or breastfeeding
- intestinal obstruction
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- uncontrolled infection
- ASA IV
- No acceptance or failure to follow protocol multimodal rehabilitation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NUTRITIONAL EFFECTS AND INFLUENCE IN THE MORBIDITY AND MORTALITY OF DIET IMMUNOMODULATORY IN FAST-TRACK SURGERY
Compare the results in terms of morbidity, mortality and hospitalization among patients with input from immunonutrients and patients with enteral nutrition intake of high calorie and high protein undergoing colorectal surgery within a multimodal rehabilitation program.
- Conditions
- IMMUNONUTRITION
- Being tested
- IMMUNONUTRITION, STANDART NUTRITION
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMMUNONUTRITIONDietary supplement
IMMUNONUTRITION SUPLEMENTS PERIOPERATIVE
STANDART NUTRITIONDietary supplement
STANDART NUTRITION PERIOPERATIVE
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | Other | STANDARD NUTRITION Receives: Dietary Supplement: STANDART NUTRITION |
| IMMUNONUTRITION | Experimental | INMUNONUTRITION Receives: Dietary Supplement: IMMUNONUTRITION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infectious complications
Measured: UP TO 30 DAYS POST-OPERATIVE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionMar 2015
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 IMMUNONUTRITIONStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Elche
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Mutua Madrileña
- Responsible party
- Principal investigator, Pedro Moya, Hospital General Universitario Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393976
- Sponsor's protocol ID
- Cirugía2
- Status last verified
- Mar 2015
- First submitted
- 16 Mar 2015
- Last updated
- 20 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moya P, Soriano-Irigaray L, Ramirez JM, Garcea A, Blasco O, Blanco FJ, Brugiotti C, Miranda E, Arroyo A. Perioperative Standard Oral Nutrition Supplements Versus Immunonutrition in Patients Undergoing Colorectal Resection in an Enhanced Recovery (ERAS) Protocol: A Multicenter Randomized Clinical Trial (SONVI Study). Medicine (Baltimore). 2016 May;95(21):e3704. doi: 10.1097/MD.0000000000003704.
PubMed 27227930
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NUTRITIONAL EFFECTS AND INFLUENCE IN THE MORBIDITY AND MORTALITY OF DIET IMMUNOMODULATORY IN FAST-TRACK SURGERY
- ClinicalTrials.gov ID
- NCT02393976
- Acronym / sponsor ID
- Cirugía2
- Conditions
- IMMUNONUTRITION
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hospital General Universitario ElcheUniversity, hospital or other
- Collaborators
- Fundación Mutua Madrileña
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 20 Mar 2015 (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.
Compare the results in terms of morbidity, mortality and hospitalization among patients with input from immunonutrients and patients with enteral nutrition intake of high calorie and high protein undergoing colorectal surgery within a multimodal rehabilitation program.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL | Other | Dietary Supplement: STANDART NUTRITIONSTANDARD NUTRITION |
| IMMUNONUTRITION | Experimental | Dietary Supplement: IMMUNONUTRITIONINMUNONUTRITION |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing colorectal surgery.
- Signing informed consent.
Key exclusion criteria (9 listed)
- Patients with no oral nutrition (dysphagia, esophageal stricture, pyloric stenosis)
- Patients with contraindications for electrical stimulation.
- Psychiatric Disorders
- HIV
- Pregnant or breastfeeding
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 |
|---|---|---|
| IMMUNONUTRITIONIMMUNONUTRITION SUPLEMENTS PERIOPERATIVE | Dietary supplement | IMMUNONUTRITION |
| STANDART NUTRITIONSTANDART NUTRITION PERIOPERATIVE | Dietary supplement | CONTROL |
Primary outcome
Infectious complications
Time frame: UP TO 30 DAYS POST-OPERATIVE
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 20 Mar 2015.
- Derived from this study: PubMed 27227930Moya P, Soriano-Irigaray L, Ramirez JM, Garcea A, Blasco O, Blanco FJ, Brugiotti C, Miranda E, Arroyo A. Perioperative Standard Oral Nutrition Supplements Versus Immunonutrition in Patients Undergoing Colorectal Resection in an Enhanced Recovery (ERAS) Protocol: A Multicenter Randomized Clinical Trial (SONVI Study). Medicine (Baltimore). 2016 May;95(21):e3704. doi: 10.1097/MD.0000000000003704.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 STANDART NUTRITION in people with IMMUNONUTRITION, run by Hospital General Universitario Elche 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 2 inclusion and 9 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 20 Mar 2015. 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?
Infectious complications (time frame: UP TO 30 DAYS POST-OPERATIVE). 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 NCT02393976, 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 20 Mar 2015.