Peripheral Parenteral Nutrition vs Conventional Fluid in Colorectal Resection in ERAS
A RANDOMIZED, CONTROLLED, CLINICAL TRIAL TO COMPARE PERIPHERAL PARENTERAL NUTRITION (PeriOlimel N4-E) VERSUS CONVENTIONAL FLUID THERAPY IN ENHANCED RECOVERY AFTER SURGERY (ERAS) PROTOCOL IN COLORECTAL CANCER SURGERY.
1 other identifier
interventional
200
1 country
1
Brief Summary
Assess if administration of early nutrition support with Perioperative Peripheral Nutrition (PeriOliclimonel) N4-E) in patients undergoing colon cancer resection in an Enhanced Recovery After Surgery (ERAS) Protocol improve the results of morbi-mortality and hospitalization versus standard intravenous fluid therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
July 19, 2018
CompletedFirst Posted
Study publicly available on registry
July 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedJuly 31, 2018
July 1, 2018
1.3 years
July 19, 2018
July 28, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
morbi-mortality
Early Peripheral Parenteral Nutrition in patients undergoing colon cancer resection in an Enhanced Recovery After Surgery Protocol to improve the results of morbi-mortality and hospitalization versus standard intravenous fluid therapy
30 days
Study Arms (2)
Perioperative peripheral parenteral nutrition
EXPERIMENTALPerioperative peripheral parenteral nutrition during 4 days
Standard fluid therapy
NO INTERVENTIONStandard fluid therap
Interventions
Eligibility Criteria
You may qualify if:
- scheduled colorectal cancer surgery
- ASA I-IV
You may not qualify if:
- Emergency surgery
- Distant metastasis
- Patient´s refusal to participate
- Allergy or hypersensitivity to egg or soy protein
- Advanced kidney or hepatic impairment
- Severe bleeding disorders
- Congenital abnormalities of amino acid metabolism
- Hyperlipidemia and severe or difficult to control hyperglycemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital General Universitario de Elche
Elche, Alicante, 03203, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antonio Arroyo, MD
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 19, 2018
First Posted
July 31, 2018
Study Start
October 1, 2016
Primary Completion
January 1, 2018
Study Completion
April 1, 2019
Last Updated
July 31, 2018
Record last verified: 2018-07