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

Not Applicable

• Conditions: Abdominal Surgery; Parenteral Nutrition; Cancer
• Interventions: Dietary Supplement: Late parenteral nutrition; Dietary Supplement: Early parenteral nutrition

• Registration Number: NCT01839617
• Lead Sponsor: Instituto do Cancer do Estado de São Paulo

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2013-04-22
• Study First Submitted QC: 2013-04-24
• Study First Posted: 2013-04-25
• Study Start: 2013-05-07
• Primary Completion: 2016-06-27
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-05
• Last Update Posted: 2018-02-07
• Study Completion: 2018-04-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 335

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Late parenteral nutrition	Late parenteral nutrition	Parenteral nutrition starts at 7th postoperative day.
Early parenteral nutrition	Early parenteral nutrition	Parenteral nutrition starts at 2nd postoperative day.

Primary Outcome Measures

Name	Time	Method
Clinical complications	30 days	respiratory, cardiovascular, renal, neurological, infectious, surgical

Secondary Outcome Measures

Name	Time	Method
Mortality	30 days	30-day mortality
Duration of pharmacologic hemodynamic support	30 days	duration of vasopressor therapy
Length of stay in ICU and in hospital	30 days	Length of stay
ICU readmission rate	30 days	ICU readmission rate
Levels of C-reactive protein	7 days	serum levels of C-reactive protein
Duration of mechanical ventilation	30 days	Duration of invasive mechanical ventilation
Liver dysfunction	30 days	liver dysfunction according SOFA

Trial Locations

Locations (2)

Cancer Institute of the State of Sao Paulo; 🇧🇷 São Paulo, SP, Brazil

ICESP; 🇧🇷 Sao Paulo, SP, Brazil