Peripheral Parenteral Nutrition vs Conventional Fluid in Colorectal Resection in ERAS

Phase 3

• Conditions: Fast-track; Colon Cancer; Parenteral Nutrition
• Interventions: Drug: Perioperative peripheral parenteral nutrition

• Registration Number: NCT03606863
• Lead Sponsor: Antonio Arroyo Sebastian

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.

Study Timeline

• Study Start: 2016-10
• Primary Completion: 2018-01
• Status Verified: 2018-07
• Study First Submitted: 2018-07-19
• Study First Submitted QC: 2018-07-28
• Last Update Submitted: 2018-07-28
• Study First Posted: 2018-07-31
• Last Update Posted: 2018-07-31
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Perioperative peripheral parenteral nutrition	Perioperative peripheral parenteral nutrition	Perioperative peripheral parenteral nutrition during 4 days

Primary Outcome Measures

Name	Time	Method
morbi-mortality	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

Trial Locations

Locations (1)

Hospital General Universitario de Elche; 🇪🇸 Elche, Alicante, Spain