IMMUNONUTRITION IN FAST-TRACK SURGERY | NCT02393976

Studies
IMMUNONUTRITION IN FAST-TRACK SURGERY

NCT02393976

Sponsor

Hospital General Universitario Elche

Status

Completed

Last Update Posted

Mar 20, 2015Estimated

Enrollment

120Actual

Phase

Not Applicable

Conditions

IMMUNONUTRITION

Interventions

IMMUNONUTRITION
STANDART NUTRITION

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Dec 2014Actual

Completion Date

Mar 2015Actual

First Submitted Date

Mar 16, 2015

First Submission Date that Met QC Criteria

Mar 19, 2015

First Posted Date

Mar 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2015

Last Update Posted Date

Mar 20, 2015Estimated

Name	Class
Fundación Mutua Madrileña	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CONTROL	Other	STANDARD NUTRITION	Dietary Supplement: STANDART NUTRITION
IMMUNONUTRITION	Experimental	INMUNONUTRITION	Dietary Supplement: IMMUNONUTRITION

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IMMUNONUTRITION	Dietary Supplement	IMMUNONUTRITION SUPLEMENTS PERIOPERATIVE	IMMUNONUTRITION

Measure	Description	Time Frame
Infectious complications		UP TO 30 DAYS POST-OPERATIVE

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing colorectal surgery.
Signing informed consent.

Exclusion Criteria:

Patients with no oral nutrition (dysphagia, esophageal stricture, pyloric stenosis)
Patients with contraindications for electrical stimulation.
Psychiatric Disorders
HIV
Pregnant or breastfeeding
intestinal obstruction
uncontrolled infection
ASA IV
No acceptance or failure to follow protocol multimodal rehabilitation.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pedro Moya		Elche	Alicante	03203	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27227930	Derived	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.

ID	Term
D004032	Diet
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena