Study on Safety, Tolerance and Metabolic Effects of a Nutritional Supplement, Given as a Drink Before Gallbladder Surgery

This study has been completed.
Sponsor:
Information provided by:
Fresenius Kabi
ClinicalTrials.gov Identifier:
NCT00662376
First received: April 17, 2008
Last updated: December 5, 2008
Last verified: November 2008
  Purpose

The aim of this pilot study is to obtain data on the safety, tolerance and metabolic effects of the oral nutritional supplement (PreOP Booster) given to patients prior to gastrointestinal surgery.


Condition Intervention
Enteral Nutrition Regimen Prior to Surgery
Dietary Supplement: PreOP Booster (oral nutritional supplement, food for special medical purposes)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Safety, Tolerance and Metabolic Effects of Using a Preoperative Oral Nutritional Supplement (PreOP Booster) in Gastrointestinal Surgery

Resource links provided by NLM:


Further study details as provided by Fresenius Kabi:

Primary Outcome Measures:
  • Safety parameters reflecting pathophysiological functions of the liver [ Time Frame: day -1, 0, 1, and 7 ] [ Designated as safety issue: No ]
  • Gastrointestinal tolerance [ Time Frame: day 0 before and 6-8h after surgery ] [ Designated as safety issue: No ]
  • Metabolic parameters in serum, liver and muscle tissue [ Time Frame: on day -1, 0, 1, and 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical parameters (infectious and non-infectious complications) [ Time Frame: until day 7 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: April 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test
oral nutritional supplement (assignment: according to consecutive random numbers)
Dietary Supplement: PreOP Booster (oral nutritional supplement, food for special medical purposes)
3 x 1 dosages of oral nutritional supplement / placebo are given prior to surgery: 2 the evening before the day of operation and 1 dosage 3-4 h before initiation of anaesthesia
Placebo Comparator: Control
placebo (assignment: according to consecutive random numbers)
Dietary Supplement: PreOP Booster (oral nutritional supplement, food for special medical purposes)
3 x 1 dosages of oral nutritional supplement / placebo are given prior to surgery: 2 the evening before the day of operation and 1 dosage 3-4 h before initiation of anaesthesia

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective laparoscopic cholecystectomy

Exclusion Criteria:

  • bile duct stones
  • ileus
  • conditions affecting gastric emptying
  • severe, organ-specific disorders
  • HIV
  • inherited metabolic disorders
  • known intolerance against or allergy to any component of the investigational feeds
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00662376

Locations
United Kingdom
Queen's Medical Centre, Division of Gastrointestinal Surgery, Nottingham University Hospitals;
Nottingham, United Kingdom
Sponsors and Collaborators
Fresenius Kabi
Investigators
Principal Investigator: Dileep N. Lobo, MS, DM, FRCS Queen's Medical Centre, Division of Gastrointestinal Surgery, Nottingham University Hospitals;
  More Information

No publications provided by Fresenius Kabi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Steffen Benzing, Kabi Innovation Centre, Fresenius Kabi Deutschland GmbH
ClinicalTrials.gov Identifier: NCT00662376     History of Changes
Other Study ID Numbers: N-POB-01-UK
Study First Received: April 17, 2008
Last Updated: December 5, 2008
Health Authority: United Kingdom: Ethics commission

ClinicalTrials.gov processed this record on July 23, 2014