NCT01839617

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
335

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 25, 2013

Completed
12 days until next milestone

Study Start

First participant enrolled

May 7, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2016

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2018

Completed
Last Updated

February 7, 2018

Status Verified

February 1, 2018

Enrollment Period

3.1 years

First QC Date

April 22, 2013

Last Update Submit

February 5, 2018

Conditions

CancerAbdominal SurgeryParenteral Nutrition

Keywords

parenteral nutritionearly nutritionabdominal surgerycancer

Outcome Measures

Primary Outcomes (1)

  • Clinical complications

    respiratory, cardiovascular, renal, neurological, infectious, surgical

    30 days

Secondary Outcomes (7)

  • Mortality

    30 days

  • Length of stay in ICU and in hospital

    30 days

  • ICU readmission rate

    30 days

  • Duration of pharmacologic hemodynamic support

    30 days

  • Levels of C-reactive protein

    7 days

  • +2 more secondary outcomes

Study Arms (2)

Early parenteral nutrition

ACTIVE COMPARATOR

Parenteral nutrition starts at 2nd postoperative day.

Dietary Supplement: Early parenteral nutrition

Late parenteral nutrition

ACTIVE COMPARATOR

Parenteral nutrition starts at 7th postoperative day.

Dietary Supplement: Late parenteral nutrition

Interventions

Early parenteral nutritionDIETARY_SUPPLEMENT
Early parenteral nutrition
Late parenteral nutritionDIETARY_SUPPLEMENT
Late parenteral nutrition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Reoperation within one year from the previous surgery. using previously parenteral nutrition.
  • Participation in another research protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cancer Institute of the State of Sao Paulo

São Paulo, São Paulo, 01246-000, Brazil

Location

ICESP

São Paulo, São Paulo, 01414001, Brazil

Location

MeSH Terms

Conditions

NeoplasmsHyperphagia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Patricia Marques, MD

    Instituto do Cancer do Estado de São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 22, 2013

First Posted

April 25, 2013

Study Start

May 7, 2013

Primary Completion

June 27, 2016

Study Completion

April 10, 2018

Last Updated

February 7, 2018

Record last verified: 2018-02

Locations

BR(2)