Fast Track in Bariatric Surgery.

Fast Track in Bariatric Surgery: A randomized clinical trial evaluating the Fast Track multimodal approach versus conventional care in Bariatric surgical candidates.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23940

Enrollment

220

Registered

2013-02-05

Start date

2013-02-05

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid obesity, laparoschopi Roux-en Y gatsric bypass, Fast Track, enhanced recovery prorammes

Interventions

Fast 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.

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

Measure	Time frame
Functional hostipal stay (time from admission to meeting predefine discharge criteria).	—

Secondary

Measure	Time frame
1. 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.	—

Measure

Time frame

1. 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.

—

Contacts

Public ContactN. Geubbels

Dept. of Surgery Slotervaart Ziekenhuis Louwesweg 6

noelle.geubbels@slz.nl+31 (0)20 5124460

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)