NCT00549237

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2007

Completed
7 days until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

September 6, 2013

Status Verified

August 1, 2013

Enrollment Period

5 years

First QC Date

October 24, 2007

Last Update Submit

September 5, 2013

Conditions

Postoperative ComplicationsGastric Bypass

Keywords

RYGBPEarly nutritionLean body massLength of stayBody Composition

Outcome Measures

Primary Outcomes (1)

  • Post-operative body mass composition

    2 years

Secondary Outcomes (2)

  • Post-operative complications

    30 days

  • Length of stay

    2 weeks

Study Arms (2)

Nutrition

ACTIVE COMPARATOR

Pre-operative Glucose load and post-operative immediate enteral nutrition

Dietary Supplement: Glucose load (Nutricia)Other: Post operative early enteral feeding

Control

NO INTERVENTION

No pre-operative glucose load. No early post-operative nutrition

Interventions

Glucose load (Nutricia)DIETARY_SUPPLEMENT

Pre-operative glucose load: 800 ml of PreOp (Nutricia) 12 h before surgery; 400 ml of PreOp (Nutricia) 2 hours before surgery

Also known as: PreOp, Nutricia
Nutrition
Post operative early enteral feedingOTHER

Enteral feeding starting 6 hours post surgery

Nutrition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • RYGBP surgery planned
  • Age over 18
  • Informed consent

You may not qualify if:

  • Previous bariatric surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires Genève

Geneva, Canton of Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dan E Azagury, MD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 24, 2007

First Posted

October 25, 2007

Study Start

November 1, 2007

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

September 6, 2013

Record last verified: 2013-08

Locations

CH(1)