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NCT03606863 Clinical Trial

Peripheral Parenteral Nutrition vs Conventional Fluid in Colorectal Resection in ERAS

Colon Cancer Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03606863
Other study ID # ELX-NPP-2016-01
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date October 2016
Est. completion date April 2019

Study information
Verified date July 2018
Source Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Contact Antonio Arroyo, MD
Phone 966 616 000
Email arroyocir@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date April 2019
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Perioperative peripheral parenteral nutrition

Locations
Country Name City State
Spain Hospital General Universitario de Elche Elche Alicante

Sponsors (1)
Lead Sponsor Collaborator
Antonio Arroyo Sebastian

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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