Bariatric Surgery Clinical Trial
— BBenchmarksOfficial title:
Defining Benchmarks in Bariatric Surgery - A Global Analysis of Laparoscopic Roux-en-Y Gastric Bypass and Sleeve Gastrectomy
Verified date | September 2019 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 classification for surgical
complications, the Comprehensive Complication Index® (CCI®) at discharge, at 3 months and at
latest follow-up. Evolution of body mass index (BMI) will be also analyzed.
Hospital eligibility: High volume centers (> 200 bariatric operations per year) from at least
three continents, maintaining a prospective database, as well as having published previously
critically on their outcome.
Study population: Adult patients who underwent primary minimally invasive (laparoscopic /
robotic) Roux-en-Y gastric bypass or sleeve gastrectomy from 1st of June 2012 to 31st of May
2017.
Patient Exclusion criteria: detailed later.
Data collection Deadline: 1st September 2017 - 30 April 2018
Status | Completed |
Enrollment | 5741 |
Est. completion date | September 17, 2019 |
Est. primary completion date | September 10, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Zurich | Zürich | Zurich |
Lead Sponsor | Collaborator |
---|---|
Marco Bueter | Dr. med. Daniel Gero, Dr. med. Dimitri A. Raptis, PhD, Dr. med. Henner Schmidt |
Switzerland,
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. — View Citation
Muller X, Marcon F, Sapisochin G, Marquez M, Dondero F, Rayar M, Doyle MMB, Callans L, Li J, Nowak G, Allard MA, Jochmans I, Jacskon K, Beltrame MC, van Reeven M, Iesari S, Cucchetti A, Sharma H, Staiger RD, Raptis DA, Petrowsky H, de Oliveira M, Hernandez-Alejandro R, Pinna AD, Lerut J, Polak WG, de Santibañes E, de Santibañes M, Cameron AM, Pirenne J, Cherqui D, Adam RA, Ericzon BG, Nashan B, Olthoff K, Shaked A, Chapman WC, Boudjema K, Soubrane O, Paugam-Burtz C, Greig PD, Grant DR, Carvalheiro A, Muiesan P, Dutkowski P, Puhan M, Clavien PA. Defining Benchmarks in Liver Transplantation: A Multicenter Outcome Analysis Determining Best Achievable Results. Ann Surg. 2018 Mar;267(3):419-425. doi: 10.1097/SLA.0000000000002477. — View Citation
Rössler F, Sapisochin G, Song G, Lin YH, Simpson MA, Hasegawa K, Laurenzi A, Sánchez Cabús S, Nunez MI, Gatti A, Beltrame MC, Slankamenac K, Greig PD, Lee SG, Chen CL, Grant DR, Pomfret EA, Kokudo N, Cherqui D, Olthoff KM, Shaked A, García-Valdecasas JC, Lerut J, Troisi RI, De Santibanes M, Petrowsky H, Puhan MA, Clavien PA. Defining Benchmarks for Major Liver Surgery: A multicenter Analysis of 5202 Living Liver Donors. Ann Surg. 2016 Sep;264(3):492-500. doi: 10.1097/SLA.0000000000001849. — View Citation
Slankamenac K, Graf R, Barkun J, Puhan MA, Clavien PA. The comprehensive complication index: a novel continuous scale to measure surgical morbidity. Ann Surg. 2013 Jul;258(1):1-7. doi: 10.1097/SLA.0b013e318296c732. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Benchmark outcomes (best achievable outcomes after bariatric surgery) | Comprehensive Complication Index (http://www.assessurgery.com/calculator_single/) | 30 days postoperatively | |
Primary | Benchmark outcomes (best achievable outcomes after bariatric surgery) | Comprehensive Complication Index (http://www.assessurgery.com/calculator_single/) | 90 days postoperatively | |
Primary | Benchmark outcomes (best achievable outcomes after bariatric surgery) | Comprehensive Complication Index (http://www.assessurgery.com/calculator_single/) | 180 days postoperatively | |
Primary | Major complications after bariatric surgery | Clavien-Dindo grade > IIIa | 30 days postoperatively | |
Primary | Major complications after bariatric surgery | Clavien-Dindo grade > IIIa | 90 days postoperatively | |
Primary | Major complications after bariatric surgery | Clavien-Dindo grade > IIIa | 180 days postoperatively | |
Secondary | Case-mix within centers | proportion of benchmark cases | 5 years | |
Secondary | Excess weight loss after bariatric surgery | Body-mass index (kg/m2) | 1-year postoperatively | |
Secondary | Excess weight loss after bariatric surgery | Body-mass index (kg/m2) | 3-years postoperatively | |
Secondary | Excess weight loss after bariatric surgery | Body-mass index (kg/m2) | 5-years postoperatively |
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