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
  Purpose

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.


Condition Intervention
Postoperative Complications
Gastric Bypass
Dietary Supplement: Glucose load (Nutricia)
Other: Post operative early enteral feeding

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Perioperative Nutrition in Gastric Bypass Surgery for Morbid Obesity

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Post-operative body mass composition [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Post-operative complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Length of stay [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: November 2007
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nutrition
Pre-operative Glucose load and post-operative immediate enteral nutrition
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
No Intervention: Control
No pre-operative glucose load. No early post-operative nutrition

Detailed Description:

Outcome measures:

  • Lean body mass
  • Length of hospital stay
  • Weight loss
  • Postoperative complications
  • Cost
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • RYGBP surgery planned
  • Age over 18
  • Informed consent

Exclusion Criteria:

  • Previous bariatric surgery
  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: NCT00549237

Locations
Switzerland
Hôpitaux Universitaires Genève
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Dan E Azagury, MD Geneva University Hospital
  More Information

No publications provided

Responsible Party: Principal investigator, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00549237     History of Changes
Other Study ID Numbers: CER 07 - 096
Study First Received: October 24, 2007
Last Updated: September 5, 2013
Health Authority: Switzerland: Federal Office of Public Health

Keywords provided by University Hospital, Geneva:
RYGBP
Early nutrition
Lean body mass
Length of stay
Body Composition

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014