Postoperative ComplicationsNCT00549237
Perioperative Nutrition in Gastric Bypass Surgery
A study testing Glucose load (Nutricia) and Post operative early enteral feeding in people with Postoperative Complications and Gastric Bypass, run by University Hospital, Geneva at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications, Gastric Bypass
- What is being tested?
- Glucose load (Nutricia) and Post operative early enteral feeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2007to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- RYGBP surgery planned
- Age over 18
- Informed consent
Who cannot join
- Previous bariatric surgery
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Hôpitaux Universitaires Genève
Geneva, Canton of Geneva, 1211
About this study
Official title: 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.
Read the detailed description
Outcome measures:
- Lean body mass
- Length of hospital stay
- Weight loss
- Postoperative complications
- Cost
- Conditions
- Postoperative Complications, Gastric Bypass
- Being tested
- Glucose load (Nutricia), Post operative early enteral feeding
- Keywords
- RYGBP, Early nutrition, Lean body mass, Length of stay, Body Composition
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose load (Nutricia)Dietary supplement
Also called PreOp, Nutricia
Pre-operative glucose load: 800 ml of PreOp (Nutricia) 12 h before surgery; 400 ml of PreOp (Nutricia) 2 hours before surgery
Post operative early enteral feedingOther
Enteral feeding starting 6 hours post surgery
| Study group | Role | What they receive |
|---|---|---|
| Nutrition | Active comparator | Pre-operative Glucose load and post-operative immediate enteral nutrition Receives: Dietary Supplement: Glucose load (Nutricia); Other: Post operative early enteral feeding |
| Control | No intervention | No pre-operative glucose load. No early post-operative nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative body mass composition
Measured: 2 years
Secondary outcomes (2)
Post-operative complications
Measured: 30 days
Length of stay
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Investigators
- Dan E Azagury, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00549237
- Sponsor's protocol ID
- CER 07 - 096
- Status last verified
- Aug 2013
- First submitted
- 24 Oct 2007
- Last updated
- 6 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Nutrition in Gastric Bypass Surgery for Morbid Obesity
- ClinicalTrials.gov ID
- NCT00549237
- Acronym / sponsor ID
- CER 07 - 096
- Conditions
- Postoperative Complications, Gastric Bypass
- Keywords
- RYGBP, Early nutrition, Lean body mass, Length of stay, Body Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 25 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Outcome measures:
- Lean body mass
- Length of hospital stay
- Weight loss
- Postoperative complications
- Cost
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition | Active comparator | Dietary Supplement: Glucose load (Nutricia), Other: Post operative early enteral feedingPre-operative Glucose load and post-operative immediate enteral nutrition |
| Control | No intervention | –No pre-operative glucose load. No early post-operative nutrition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- RYGBP surgery planned
- Age over 18
- Informed consent
Key exclusion criteria (1 listed)
- Previous bariatric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose load (Nutricia)Also: PreOp, NutriciaPre-operative glucose load: 800 ml of PreOp (Nutricia) 12 h before surgery; 400 ml of PreOp (Nutricia) 2 hours before surgery | Dietary supplement | Nutrition |
| Post operative early enteral feedingEnteral feeding starting 6 hours post surgery | Other | Nutrition |
Primary outcome
Post-operative body mass composition
Time frame: 2 years
2 secondary outcomes
Post-operative complications
Time frame: 30 days
Length of stay
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan E Azagury, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose load (Nutricia) and Post operative early enteral feeding in people with Postoperative Complications and Gastric Bypass, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative body mass composition (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2013.