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Perioperative Nutrition in Gastric Bypass Surgery

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00549237
First received: October 24, 2007
Last updated: September 5, 2013
Last verified: August 2013

October 24, 2007
September 5, 2013
November 2007
November 2012   (final data collection date for primary outcome measure)
Post-operative body mass composition [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Post operative body mass composition [ Time Frame: 2 years ]
Complete list of historical versions of study NCT00549237 on ClinicalTrials.gov Archive Site
  • Post-operative complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Length of stay [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Post operative complications [ Time Frame: 30 days ]
  • Lenght of stay
Not Provided
Not Provided
 
Perioperative Nutrition in Gastric Bypass Surgery
Perioperative Nutrition in Gastric Bypass Surgery for Morbid Obesity

The aim of this study is to demonstrate the influence of peri-operative nutrition on the preservation of lean body mass after gastric bypass, as well as it's influence on postoperative complications.

Outcome measures:

  • Lean body mass
  • Length of hospital stay
  • Weight loss
  • Postoperative complications
  • Cost
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Postoperative Complications
  • Gastric Bypass
  • Dietary Supplement: Glucose load (Nutricia)
    Pre-operative glucose load: 800 ml of PreOp (Nutricia) 12 h before surgery; 400 ml of PreOp (Nutricia) 2 hours before surgery
    Other Name: PreOp, Nutricia
  • Other: Post operative early enteral feeding
    Enteral feeding starting 6 hours post surgery
  • Active Comparator: Nutrition
    Pre-operative Glucose load and post-operative immediate enteral nutrition
    Interventions:
    • Dietary Supplement: Glucose load (Nutricia)
    • Other: Post operative early enteral feeding
  • No Intervention: Control
    No pre-operative glucose load. No early post-operative nutrition
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
November 2012
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • RYGBP surgery planned
  • Age over 18
  • Informed consent

Exclusion Criteria:

  • Previous bariatric surgery
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00549237
CER 07 - 096
No
Principal investigator, University Hospital, Geneva
University Hospital, Geneva
Not Provided
Principal Investigator: Dan E Azagury, MD Geneva University Hospital
University Hospital, Geneva
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP