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Preoperative Oral Nutritional Supplement (preOP Booster) in Visceral Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00503334
First Posted: July 18, 2007
Last Update Posted: December 8, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Fresenius Kabi
  Purpose
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.

Condition Intervention
Enteral Nutrition (Food for Special Medical Purposes) Dietary Supplement: preOP booster (oral nutritional supplement, food for special medical purposes)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Efficacy and Tolerability of a Preoperative Oral Nutritional Supplement (preOP Booster) Versus Placebo in Visceral Surgery

Resource links provided by NLM:


Further study details as provided by Fresenius Kabi:

Primary Outcome Measures:
  • laboratory measurements: total endogenous antioxidant capacity, free radicals, CRP; [ Time Frame: up to 30 days after surgery ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 36
Study Start Date: July 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective pancreaticoduodenectomy

Exclusion Criteria:

  • Concomitant chemotherapy
  • Severe malnutrition (SGA score C)
  • Conditions affecting gastric emptying
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00503334


Locations
Italy
Università Salute-Vita San Raffaele,
Milan, Italy, 20132
Sponsors and Collaborators
Fresenius Kabi
Investigators
Principal Investigator: Marco Braga, Prof MD Università Salute-Vita San Raffaele, Milan, Italy
  More Information

Responsible Party: Dr. Steffen Benzing, Fresenius Kabi Deutschland GmbH
ClinicalTrials.gov Identifier: NCT00503334     History of Changes
Other Study ID Numbers: N-POB-03-IT
First Submitted: July 16, 2007
First Posted: July 18, 2007
Last Update Posted: December 8, 2008
Last Verified: November 2008