Peripheral Parenteral Nutrition vs Conventional Fluid in Colorectal Resection in ERAS

Antonio Arroyo Sebastian

Status and phase: Unknown; Phase 3

Conditions: Colon Cancer; Parenteral Nutrition; Fast-track

Treatments: Drug: Perioperative peripheral parenteral nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT03606863

ELX-NPP-2016-01

Details and patient eligibility

About

Assess if administration of early nutrition support with Perioperative Peripheral Nutrition (PeriOliclimonel) N4-E) in patients undergoing colon cancer resection in an Enhanced Recovery After Surgery (ERAS) Protocol improve the results of morbi-mortality and hospitalization versus standard intravenous fluid therapy.

Full description

The main objective is to determine if perioperative nutritional support with PeriOlimel N4-E, that reaches nutritional requirements of ERAS protocol for colorectal cancer surgery patients, can improve nutritional status so it decreases postoperative complications, hospital length of stay and costs, compared to conventional fluid therapy administration since patients receive oral nutrition at day 3-5.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• scheduled colorectal cancer surgery
• ASA I-IV

Exclusion criteria

• Emergency surgery
• Distant metastasis
• Patient´s refusal to participate
• Allergy or hypersensitivity to egg or soy protein
• Advanced kidney or hepatic impairment
• Severe bleeding disorders
• Congenital abnormalities of amino acid metabolism
• Hyperlipidemia and severe or difficult to control hyperglycemia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

Perioperative peripheral parenteral nutrition

Experimental group

Description:

Perioperative peripheral parenteral nutrition during 4 days

Treatment:

Drug: Perioperative peripheral parenteral nutrition

Standard fluid therapy

No Intervention group

Description:

Standard fluid therap