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

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ClinicalTrials.gov Identifier: NCT00662376
Recruitment Status : Completed
First Posted : April 21, 2008
Last Update Posted : December 8, 2008
Sponsor:
Information provided by:
Fresenius Kabi

Brief Summary:
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 or disease Intervention/treatment
Enteral Nutrition Regimen Prior to Surgery Dietary Supplement: PreOP Booster (oral nutritional supplement, food for special medical purposes)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Safety, Tolerance and Metabolic Effects of Using a Preoperative Oral Nutritional Supplement (PreOP Booster) in Gastrointestinal Surgery
Study Start Date : April 2008
Primary Completion Date : October 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Safety parameters reflecting pathophysiological functions of the liver [ Time Frame: day -1, 0, 1, and 7 ]
  2. Gastrointestinal tolerance [ Time Frame: day 0 before and 6-8h after surgery ]
  3. Metabolic parameters in serum, liver and muscle tissue [ Time Frame: on day -1, 0, 1, and 7 ]

Secondary Outcome Measures :
  1. Clinical parameters (infectious and non-infectious complications) [ Time Frame: until day 7 ]


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 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

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): 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;