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Preoperative Oral Nutritional Supplement (preOP Booster) in Visceral Surgery

NCT ID: NCT00503334

Last Updated: 2008-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Enteral Nutrition (Food for Special Medical Purposes)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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preOP booster

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

3x1 dosage pre-operatively

preOP booster placebo

Group Type PLACEBO_COMPARATOR

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

Intervention Type DIETARY_SUPPLEMENT

3x1 dosage pre-operatively

Interventions

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

3x1 dosage pre-operatively

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Elective pancreaticoduodenectomy

Exclusion Criteria

* Concomitant chemotherapy
* Severe malnutrition (SGA score C)
* Conditions affecting gastric emptying
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fresenius Kabi

INDUSTRY

Sponsor Role lead

Responsible Party

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Fresenius Kabi Deutschland GmbH

Principal Investigators

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Marco Braga, Prof MD

Role: PRINCIPAL_INVESTIGATOR

Università Salute-Vita San Raffaele, Milan, Italy

Locations

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Università Salute-Vita San Raffaele,

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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N-POB-03-IT

Identifier Type: -

Identifier Source: org_study_id