NCT02393976

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

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

January 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 20, 2015

Completed
Last Updated

March 20, 2015

Status Verified

March 1, 2015

Enrollment Period

11 months

First QC Date

March 16, 2015

Last Update Submit

March 19, 2015

Conditions

IMMUNONUTRITION

Outcome Measures

Primary Outcomes (1)

  • Infectious complications

    UP TO 30 DAYS POST-OPERATIVE

Study Arms (2)

CONTROL

OTHER

STANDARD NUTRITION

Dietary Supplement: STANDART NUTRITION

IMMUNONUTRITION

EXPERIMENTAL

INMUNONUTRITION

Dietary Supplement: IMMUNONUTRITION

Interventions

IMMUNONUTRITIONDIETARY_SUPPLEMENT

IMMUNONUTRITION SUPLEMENTS PERIOPERATIVE

IMMUNONUTRITION
STANDART NUTRITIONDIETARY_SUPPLEMENT

STANDART NUTRITION PERIOPERATIVE

CONTROL

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing colorectal surgery.
  • Signing informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pedro Moya

Elche, Alicante, 03203, Spain

Location

Related Publications (1)

  • 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.

    PMID: 27227930DERIVED

MeSH Terms

Interventions

Immunonutrition Diet

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD

Study Record Dates

First Submitted

March 16, 2015

First Posted

March 20, 2015

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Study Completion

March 1, 2015

Last Updated

March 20, 2015

Record last verified: 2015-03

Locations

ES(1)