Perioperative Nutrition in Gastric Bypass Surgery - Full Text View

Sponsored by:	University Hospital, Geneva
Information provided by:	University Hospital, Geneva
ClinicalTrials.gov Identifier:	NCT00549237

Purpose

The aim 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
Body Composition Postoperative Complications Length of Stay	Dietary Supplement: Glucose load (Nutricia) Other: Post operative early enteral feeding

MedlinePlus related topics: Obesity

Drug Information available for: Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Perioperative Nutrition in Gastric Bypass Surgery for Morbid Obesity

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:

Post operative body mass composition [ Time Frame: 2 years ]

Secondary Outcome Measures:

Post operative complications [ Time Frame: 30 days ]
Lenght of stay

Estimated Enrollment:	190
Study Start Date:	November 2007
Estimated Study Completion Date:	November 2009

Arms	Assigned Interventions
Nutrition: Active Comparator Preoperative Glucose load and Post operative immediate enteral nutrition	Dietary Supplement: Glucose load (Nutricia) Pre opertative glucose load: 800 ml of PreOp (Nutricia) 12h before surgery; 400 ml of PreOp (Nutricia) 2 hours before surgery Other: Post operative early enteral feeding Enteral feeding starting 6 hours post surgery
Control: No Intervention 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549237

Contacts

Contact: Dan E Azagury, MD	+41223727704	dan.azagury@hcuge.ch
Contact: Olivier Huber, PD	+41223727704	olivier.huber@hcuge.ch

Locations

Switzerland
Hôpitaux Universitaires Genève	Recruiting
Geneva, Switzerland, 1211

Sponsors and Collaborators

University Hospital, Geneva

Investigators

Principal Investigator:

Dan E Azagury, MD

Geneva University Hospital

More Information

Study ID Numbers:	CER 07 - 096
Study First Received:	October 24, 2007
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00549237
Health Authority:	Switzerland: Federal Office of Public Health

Keywords provided by University Hospital, Geneva:

RYGBP
Early nutrition
Lean body mass

Study placed in the following topic categories:

Obesity
Postoperative Complications
Obesity, Morbid

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 15, 2009