Study Comparing Early and Late Nutrition in Cancer Patients Undergoing Abdominal Surgery

NCT ID: NCT01839617

Last Updated: 2018-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

335 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-07

Study Completion Date

2018-04-10

Brief Summary

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The aim of this study is to find which is the best nutritional strategy in cancer patients undergoing abdominal surgery regarding postoperative complications.

Detailed Description

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There is a controversy regarding the timing of initiation of parenteral nutrition in cancer patients undergoing abdominal surgery in whom caloric targets cannot be met by enteral nutrition alone.

This is a randomized and controlled trial comparing early initiation with late initiation of parenteral nutrition.

Early-initiation group: patients will be randomized to initiate parenteral nutrition in the 2nd day after surgery.

Late-initiation group: patients will be randomized to initiate parenteral nutrition in the 7th day after surgery.

Calculations regarding the caloric goal included protein energy and were based on corrected ideal body weight, age and sex. When oral or enteral nutrition covered 80% of the calculated caloric goal, parenteral nutrition was reduced and progressively stopped.

Conditions

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Cancer Abdominal Surgery Parenteral Nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Early parenteral nutrition

Parenteral nutrition starts at 2nd postoperative day.

Group Type ACTIVE_COMPARATOR

Early parenteral nutrition

Intervention Type DIETARY_SUPPLEMENT

Late parenteral nutrition

Parenteral nutrition starts at 7th postoperative day.

Group Type ACTIVE_COMPARATOR

Late parenteral nutrition

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Early parenteral nutrition

Intervention Type DIETARY_SUPPLEMENT

Late parenteral nutrition

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Older than 18 years
* Laparotomy for abdominal cancer surgery: urological, gynecological, digestive, abdominal sarcomas and melanomas, lymphomas and abdominal vascular.
* Informed consent form signed by the patient or legal guardian.

Exclusion Criteria

* Reoperation within one year from the previous surgery. using previously parenteral nutrition.
* Participation in another research protocol.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto do Cancer do Estado de São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Patrícia Camargo Marques

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patricia Marques, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto do Cancer do Estado de São Paulo

Locations

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Cancer Institute of the State of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

ICESP

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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ICESP

Identifier Type: -

Identifier Source: org_study_id

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