Status:
COMPLETED
Defining Benchmarks in Bariatric Surgery
Lead Sponsor:
Marco Bueter
Collaborating Sponsors:
Dr. med. Daniel Gero
Dr. med. Dimitri A. Raptis, PhD
Conditions:
Benchmark
Bariatric Surgery
Eligibility:
All Genders
18-65 years
Brief Summary
Aim: To define benchmark outcomes in minimally-invasive primary bariatric surgery. Design: Multicenter retrospective cohort study. Assessed outcomes: Morbidity as defined by the Clavien-Dindo classi...
Detailed Description
Background With the growing complexity and cost of modern surgical practice, quality assessment becomes mandatory. The notion of quality and quality assessment is widely recognized and used in the wor...
Eligibility Criteria
Inclusion
- Adult patients of 18-65 years
- Low risk profile (please read "exclusion criteria"),
- Maximum preoperative BMI of 50 kg/m2
- Primary laparoscopic/robotic proximal Roux-en-Y gastric bypass or sleeve gastrectomy
- Documented follow-up of at least 90 days
Exclusion
- Open surgery
- Previous intra-abdominal surgery (including previous bariatric surgery)
- Pre-operative BMI over 50 kg/m2
- Age over 65 years
- Cardiovascular disease (e.g. cardiac arrhythmia, stroke, coronary artery disease) (Hypertension is allowed)
- History of thromboembolic events and/or therapeutic anticoagulation
- Diabetes mellitus (Type I and Type II, as defined by the American Diabetes Association)
- Obstructive sleep apnea (recurrent episodes of upper airway collapse during sleep)
- Chronic obstructive pulmonary disease (FEV1/FVC\<0.7)
- Chronic kidney disease (eGFR \< 30ml/min/1.72 m2)
- Inflammatory bowel disease (ulcerative colitis, Crohn's)
- Immunosuppression therapy (e.g. steroids, calcineurin inhibitors, etc)
- Patients who underwent associated procedures (for example: cholecystectomy, hiatoplasty, liver biopsy)
- ASA score \> 2
Key Trial Info
Start Date :
October 17 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 17 2019
Estimated Enrollment :
5741 Patients enrolled
Trial Details
Trial ID
NCT03440138
Start Date
October 17 2017
End Date
September 17 2019
Last Update
September 19 2019
Active Locations (1)
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1
University Hospital Zurich
Zurich, Canton of Zurich, Switzerland, 8091