Preoperative Oral Nutritional Supplement (preOP Booster) in Visceral Surgery

This study has been completed.
Sponsor:
Information provided by:
Fresenius Kabi
ClinicalTrials.gov Identifier:
NCT00503334
First received: July 16, 2007
Last updated: December 5, 2008
Last verified: November 2008
  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 Blind (Subject, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Steffen Benzing, Fresenius Kabi Deutschland GmbH
ClinicalTrials.gov Identifier: NCT00503334     History of Changes
Other Study ID Numbers: N-POB-03-IT
Study First Received: July 16, 2007
Last Updated: December 5, 2008
Health Authority: Italy: Ethics Committee

ClinicalTrials.gov processed this record on September 22, 2014