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NCT00549237 Clinical Trial

Perioperative Nutrition in Gastric Bypass Surgery

Postoperative Complications Clinical Trial

Official title:
Perioperative Nutrition in Gastric Bypass Surgery for Morbid Obesity

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00549237
Other study ID # CER 07 - 096
Secondary ID
Status Completed
Phase N/A
First received October 24, 2007
Last updated September 5, 2013
Start date November 2007
Est. completion date November 2012

Study information
Verified date August 2013
Source University Hospital, Geneva
Contact n/a
Is FDA regulated No
Health authority Switzerland: Federal Office of Public Health
Study type Interventional

Clinical Trial Summary

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.

Description:

Outcome measures:

- Lean body mass

- Length of hospital stay

- Weight loss

- Postoperative complications

- Cost

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- RYGBP surgery planned

- Age over 18

- Informed consent

Exclusion Criteria:

- Previous bariatric surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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:
• Post operative early enteral feeding
Enteral feeding starting 6 hours post surgery

Locations
Country Name City State
Switzerland Hôpitaux Universitaires Genève Geneva

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Post-operative body mass composition 2 years No
Secondary Post-operative complications 30 days Yes
Secondary Length of stay 2 weeks No
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