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Completed

NCT Number: NCT00503334

Preoperative Oral Nutritional Supplement (preOP Booster) in Visceral Surgery

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.

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Key information

Conditions

Enteral Nutrition (Food for Special Medical Purposes)

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Università Salute-Vita San Raffaele,

Milan, 20132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective pancreaticoduodenectomy

Exclusion criteria

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

Treatment and study plan

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

Dietary Supplement

3x1 dosage pre-operatively

Primary outcomes

  1. laboratory measurements: total endogenous antioxidant capacity, free radicals, CRP;

    Time frame: up to 30 days after surgery

Secondary outcomes

  1. postoperative complications, pre- and postoperative discomfort (well-being), muscle strength at 7 days post-op, length of stay (hospital / ICU), ambulation time, gastro intestinal tolerance

    Time frame: up to 30 days after surgery

Sponsors and collaborators

Lead sponsor

Fresenius Kabi

Industry

Registry information

Official study title

Efficacy and Tolerability of a Preoperative Oral Nutritional Supplement (preOP Booster) Versus Placebo in Visceral Surgery

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 18, 2007
Registry last updated
Dec 8, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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