Peripheral Parenteral Nutrition vs Conventional Fluid in Colorectal Resection in ERAS

July 28, 2018 updated by: Antonio Arroyo Sebastian

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The main objective is to determine if perioperative nutritional support with PeriOlimel N4-E, that reaches nutritional requirements of ERAS protocol for colorectal cancer surgery patients, can improve nutritional status so it decreases postoperative complications, hospital length of stay and costs, compared to conventional fluid therapy administration since patients receive oral nutrition at day 3-5.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Recruiting
        • Hospital General Universitario de Elche
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • scheduled colorectal cancer surgery
  • ASA I-IV

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Perioperative peripheral parenteral nutrition
Perioperative peripheral parenteral nutrition during 4 days
Drug: Perioperative peripheral parenteral nutrition
No Intervention: Standard fluid therapy
Standard fluid therap

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
morbi-mortality
Time Frame: 30 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antonio Arroyo Sebastian

Investigators

  • Principal Investigator: Antonio Arroyo, MD, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

January 1, 2018

Study Completion (Anticipated)

April 1, 2019

Study Registration Dates

First Submitted

July 19, 2018

First Submitted That Met QC Criteria

July 28, 2018

First Posted (Actual)

July 31, 2018

Study Record Updates

Last Update Posted (Actual)

July 31, 2018

Last Update Submitted That Met QC Criteria

July 28, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELX-NPP-2016-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colon Cancer

Clinical Trials on Perioperative peripheral parenteral nutrition

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe