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

Instituto do Cancer do Estado de São Paulo

Status: Unknown

Conditions: Parenteral Nutrition; Abdominal Surgery; Cancer

Treatments: Dietary Supplement: Early parenteral nutrition; Dietary Supplement: Late parenteral nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT01839617

ICESP

Details and patient eligibility

About

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

Full 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.

Enrollment: 335 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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335 participants in 2 patient groups

Early parenteral nutrition

Active Comparator group

Description:

Parenteral nutrition starts at 2nd postoperative day.

Treatment:

Dietary Supplement: Early parenteral nutrition

Late parenteral nutrition

Active Comparator group

Description:

Parenteral nutrition starts at 7th postoperative day.

Treatment:

Dietary Supplement: Late parenteral nutrition