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Trial record 89 of 978 for:    colon cancer AND resection

Peripheral Parenteral Nutrition vs Conventional Fluid in Colorectal Resection in ERAS

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ClinicalTrials.gov Identifier: NCT03606863
Recruitment Status : Recruiting
First Posted : July 31, 2018
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Antonio Arroyo Sebastian, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

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.

Condition or disease Intervention/treatment Phase
Colon Cancer Parenteral Nutrition Fast-track Drug: Perioperative peripheral parenteral nutrition Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : October 2016
Actual Primary Completion Date : January 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03606863


Contacts
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Contact: Antonio Arroyo, MD 966 616 000 arroyocir@hotmail.com

Locations
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Spain
Hospital General Universitario de Elche Recruiting
Elche, Alicante, Spain, 03203
Contact: ANTONIO ARROYO, MD    966 616 000    arroyocir@hotmail.com   
Sponsors and Collaborators
Antonio Arroyo Sebastian
Investigators
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Principal Investigator: Antonio Arroyo, MD Fundación para el fomento de la investigación sanitaria y biomédica de la Comunidad Valenciana

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Responsible Party: Antonio Arroyo Sebastian, Principal Investigator, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
ClinicalTrials.gov Identifier: NCT03606863     History of Changes
Other Study ID Numbers: ELX-NPP-2016-01
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided