Peripheral Parenteral Nutrition vs Conventional Fluid in... | NCT03606863

Studies
Peripheral Parenteral Nutrition vs Conventional Fluid in Colorectal Resection in ERAS

NCT03606863

Sponsor

Antonio Arroyo Sebastian

Status

Unknown status

Last Update Posted

Jul 31, 2018Actual

Enrollment

200Estimated

Phase

Phase 3

Conditions

Colon Cancer
Parenteral Nutrition
Fast-track

Interventions

Perioperative peripheral parenteral nutrition

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016Actual

Primary Completion Date

Jan 2018Actual

Completion Date

Apr 2019Estimated

First Submitted Date

Jul 19, 2018

First Submission Date that Met QC Criteria

Jul 28, 2018

First Posted Date

Jul 31, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2018

Last Update Posted Date

Jul 31, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Antonio Arroyo Sebastian, Principal Investigator, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat ValencianaSponsor-Investigator

Lead Sponsor

Antonio Arroyo SebastianOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Perioperative peripheral parenteral nutrition	Experimental	Perioperative peripheral parenteral nutrition during 4 days	Drug: Perioperative peripheral parenteral nutrition
Standard fluid therapy	No Intervention	Standard fluid therap

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Perioperative peripheral parenteral nutrition	Drug		Perioperative peripheral parenteral nutrition

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Antonio Arroyo, MD	Contact	966 616 000		arroyocir@hotmail.com

Overall Officials

Name	Affiliation	Role
Antonio Arroyo, MD	Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital General Universitario de Elche	Recruiting	Elche	Alicante	03203	Spain

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms
D006963	Hyperphagia

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

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Browse Branches

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