Preoperative Oral Nutritional Supplement (preOP Booster) in Visceral Surgery

Fresenius Kabi

Status: Completed

Conditions: Enteral Nutrition (Food for Special Medical Purposes)

Treatments: Dietary Supplement: preOP booster (oral nutritional supplement, food for special medical purposes)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00503334

N-POB-03-IT

Details and patient eligibility

About

The purpose of this pilot study is to investigate the effect of an oral nutritional supplement (preOP booster) versus placebo regarding metabolic criteria in patients undergoing elective pancreaticoduodenectomy.

Enrollment: 36 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elective pancreaticoduodenectomy

Exclusion criteria

• Concomitant chemotherapy
• Severe malnutrition (SGA score C)
• Conditions affecting gastric emptying

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups, including a placebo group

preOP booster

Experimental group

Treatment:

Dietary Supplement: preOP booster (oral nutritional supplement, food for special medical purposes)

preOP booster placebo

Placebo Comparator group

Treatment:

Dietary Supplement: preOP booster (oral nutritional supplement, food for special medical purposes)