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

Fresenius Kabi1 site in 1 country36 target enrollmentJuly 2007

ConditionsEnteral Nutrition (Food for Special Medical Purposes)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Enteral Nutrition (Food for Special Medical Purposes)
Sponsor: Fresenius Kabi
Enrollment: 36
Locations: 1
Primary Endpoint: laboratory measurements: total endogenous antioxidant capacity, free radicals, CRP;
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 2007

End Date

May 2008

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Fresenius Kabi

Eligibility Criteria

Inclusion Criteria

•Elective pancreaticoduodenectomy

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: up to 30 days after surgery

Secondary Outcomes

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(up to 30 days after surgery)