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

Phase 3
18 Years
Not Enrolling
Postoperative Abdominal Surgery for Cancer

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Trial Information

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

The abdominal surgeries are typically susceptible to postoperative complications with
consequences for food late. Prolonged fasting affects the individual as a whole as well as
the surgical procedure he underwent (Wilmore, 2000). Neoplasias undergoing surgery, bring
with them other than the consequences of endocrine and metabolic response to trauma inherent
in the surgical procedure, the condition of aggregate increased metabolic consumption of own
adversities and neoplastic disease. There are rarely committed by or associated secondary
morbidity such as diabetes, renal dysfunction as a basis, respiratory, cardiac or hepatic
impairment and chronic inflammation and worsen dramatically as well as social issues such as
smoking, alcohol consumption, no adequate acess of quality of food (J Daley, 1997). We
understand that patients with cancer are special when we noticed that all are at nutritional
risk or already have some degree of malnutrition. The postoperative performance will be
influenced by this status before surgery and should be targeted for specific nutritional
support (Mariette C, 2012). The purpose of this study is to determine, in this specific
population, the best time to begin any nutritional mode, either parenteral or
gastrointestinal tract, or how long we can shorten or observe fasting and measure the
consequences of all these interventions or expectations. The intention is to bring the
methodology used for the publication of the NEJM study, 2011 for the specific population
with cancer surgery. It compares the clinical postoperative according to nutritional
strategy (early or late). We propose the division between two randomized groups, totaling
335 people, in which the first will receive the first 48 hours of postoperative parenteral
nutrition as it adapts to nutrition digestive tract. The second group will receive
parenteral nutrition only after the eighth day if did not achieve success feeding
gastrointestinal tract naturally.

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

- Participation in another research protocol.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

incidence of clinical complications

Outcome Description:

respiratory, cardiovascular, renal, neurological, infectious, abdominal surgical

Outcome Time Frame:

30 days

Safety Issue:



Brazil: National Committee of Ethics in Research

Study ID:




Start Date:

May 2013

Completion Date:

June 2014

Related Keywords:

  • Postoperative Abdominal Surgery for Cancer
  • parenteral nutrition
  • early nutrition
  • abdominal surgery
  • cancer
  • oncological surgery
  • prolonged fasting
  • determine the best time to start nutrition