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

Sponsored by:	Fresenius Kabi
Information provided by:	Fresenius Kabi
ClinicalTrials.gov Identifier:	NCT00662376

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)

MedlinePlus related topics: Dietary Supplements

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Safety, Tolerance and Metabolic Effects of Using a Preoperative Oral Nutritional Supplement (PreOP Booster) in Gastrointestinal Surgery

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
Test: Experimental 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
Control: Placebo Comparator 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

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

Responsible Party:	Kabi Innovation Centre, Fresenius Kabi Deutschland GmbH ( Dr. Steffen Benzing )
Study ID Numbers:	N-POB-01-UK
Study First Received:	April 17, 2008
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00662376
Health Authority:	United Kingdom: Ethics commission

ClinicalTrials.gov processed this record on January 16, 2009