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Fast Track in Bariatric Surgery.


- candidate number14325
- NTR NumberNTR3853
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-feb-2013
- Secondary IDsNL42006.048.12 CCMO
- Public TitleFast Track in Bariatric Surgery.
- Scientific TitleFast Track in Bariatric Surgery: A randomized clinical trial evaluating the Fast Track multimodal approach versus conventional care in Bariatric surgical candidates.
- ACRONYMFast Track Study
- hypothesisThis study aims to clarify the hypothesized benefits of fast track surgery in the bariatric surgery population.
- Healt Condition(s) or Problem(s) studiedMorbid obesity , fast track care, Laparoschopi Roux-en Y gatsric bypass
- Inclusion criteria1. Age: 18-65 years;
2. Male or female;
3. BMI of ≥40 or ≥35 plus one or more of the obesity related co morbidities (hypertension, T2DM, sleep apnea, hypercholesterolemia and arthrosis);
4. Scheduled for lap-RYGB.
- Exclusion criteria1. Patients with T2DM requiring insulin;
2. Patients living more than one hour by car from the hospital;
3. Patients with an American Society of Anaesthesiologist Classification (ASA) of >3;
4. Patients with an OS-MRS of >3, corresponding with an 'intermediate' surgical risk;
5. Patients requiring another surgical intervention than the lap-RYGB (e.g. cholecystectomy of ventral hernia repair) in the same session;
6. Patients requiring revisional bariatric procedures (so called 'redo's');
7. Patients with insufficient knowledge of the Dutch language to complete the Quality of Life Questionnaires;
8. Patients participating in any other (therapeutic) study that may influence primary or secondary outcomes.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 5-feb-2013
- planned closingdate5-aug-2014
- Target number of participants220
- InterventionsFast Track multmodal programme:
Pre operative:
1. Counseling;
2. Avoiding benzodiazepines/opiates.
Operative:
1. Switch of dosage anaesthetics (high remifentanil, low propofol);
2. Infiltration of trocard site swith local anaestetics.
Postoperative:
1. Clear analgetic protocol (avoiding opiates);
2. Clear anti-emetic protocol;
3. Mobilisation 1 h postoperative;
4. Clear liquid 1h after surgery;
5. Careful administration of intravenous fluids.

The control group will receive conventional care.
- Primary outcomeFunctional hostipal stay (time from admission to meeting predefine discharge criteria).
- Secondary outcome1. Total hostipal stay;
2. Short term (30-day) complications;
3. Prevalence of pain and analgetic consumption;
4. Prevalence of nausea/vomiting and anti-emetic consumption;
5. Time to mobilisation;
6. Fluid and medication requirements during anaesthesia;
7. 30 day mortality;
8. 30 day readmission;
9. QoL (specific and generic);
10. Producedure times;
11. Feasibility of the Fast Track programme;
12. Cost effectiveness.
- Timepoints30 days (1 month).
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES N. Geubbels
- CONTACT for SCIENTIFIC QUERIES N. Geubbels
- Sponsor/Initiator Slotervaart hospital
- Funding
(Source(s) of Monetary or Material Support)
Slotervaart hospital
- PublicationsN/A
- Brief summaryThis study aims to clarify the hypothesized benefits of fast track surgery in the bariatric surgery population. Fast track has been proven to be a safe and effective method to reduce the postoperative recovery time in other surgical fields (mainly colorectal). A steep increase in the prevalence of morbid obesity in the Dutch population accumulated with the fact that bariatric surgery is currently the only long term effective solution for this problem warrants more standardized care from our hospital in order to comply with the increasing volume of patients. In our hospital we have begun implementing elements of the Fast Track programme since 2011. This has led to a drastic decrease in admission duration from about 5 to 2 days. The current standard of care in bariatric procedures is excellent in comparison to international data, with a low mortality and morbidity rate. But observational studies investigating the role of fast track in bariatric surgical programmes hint that there may still be merit to gain. However, currently there is no scientific evidence available to strengthen this hypothesis due to the lack of blinded randomized trials in the bariatric subpopulation.
- Main changes (audit trail)
- RECORD5-feb-2013 - 25-feb-2013


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