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Peripheral Parenteral Nutrition vs Conventional Fluid in Colorectal Resection in ERAS

Primary Purpose

Colon Cancer, Parenteral Nutrition, Fast-track

Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Perioperative peripheral parenteral nutrition
Sponsored by
Antonio Arroyo Sebastian
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital General Universitario de ElcheRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Perioperative peripheral parenteral nutrition

Standard fluid therapy

Arm Description

Perioperative peripheral parenteral nutrition during 4 days

Standard fluid therap

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 19, 2018
Last Updated
July 28, 2018
Sponsor
Antonio Arroyo Sebastian
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1. Study Identification

Unique Protocol Identification Number
NCT03606863
Brief Title
Peripheral Parenteral Nutrition vs Conventional Fluid in Colorectal Resection in ERAS
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
April 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Antonio Arroyo Sebastian

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Parenteral Nutrition, Fast-track

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Perioperative peripheral parenteral nutrition
Arm Type
Experimental
Arm Description
Perioperative peripheral parenteral nutrition during 4 days
Arm Title
Standard fluid therapy
Arm Type
No Intervention
Arm Description
Standard fluid therap
Intervention Type
Drug
Intervention Name(s)
Perioperative peripheral parenteral nutrition
Primary Outcome Measure Information:
Title
morbi-mortality
Description
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
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Arroyo, MD
Phone
966 616 000
Email
arroyocir@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Arroyo, MD
Organizational Affiliation
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General Universitario de Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ANTONIO ARROYO, MD
Phone
966 616 000
Email
arroyocir@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Peripheral Parenteral Nutrition vs Conventional Fluid in Colorectal Resection in ERAS

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