Preoperative Oral Nutritional Supplement (preOP Booster) in Visceral Surgery

December 5, 2008 updated by: Fresenius Kabi

Efficacy and Tolerability of a Preoperative Oral Nutritional Supplement (preOP Booster) Versus Placebo 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20132
        • Università Salute-Vita San Raffaele,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elective pancreaticoduodenectomy

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: preOP booster
Dietary supplement: preOP booster (oral nutritional supplement, food for special medical purposes)
3x1 dosage pre-operatively
Placebo Comparator: preOP booster placebo
Dietary supplement: preOP booster (oral nutritional supplement, food for special medical purposes)
3x1 dosage pre-operatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
laboratory measurements: total endogenous antioxidant capacity, free radicals, CRP;
Time Frame: up to 30 days after surgery
up to 30 days after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
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
up to 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fresenius Kabi

Investigators

  • Principal Investigator: Marco Braga, Prof MD, Università Salute-Vita San Raffaele, Milan, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

July 16, 2007

First Submitted That Met QC Criteria

July 17, 2007

First Posted (Estimate)

July 18, 2007

Study Record Updates

Last Update Posted (Estimate)

December 8, 2008

Last Update Submitted That Met QC Criteria

December 5, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Other Study ID Numbers

  • N-POB-03-IT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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