Cardiovascular Risk Factors of Medical and Septic Complications After Laparoscopic Bariatric Surgery
NCT ID: NCT04683666
Last Updated: 2020-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
177 participants
OBSERVATIONAL
2013-03-15
2020-06-15
Brief Summary
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Detailed Description
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A prospective, observational study of all morbidly obese patients undergoing laparoscopic Roux-en-Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) was performed. We evaluated preoperative comorbidities and cardiovascular risk factors, and the appearance of postoperative complications up to 90 days after surgery.
Evaluated cardiovascular risk factors include age, the presence of tobacco habit, preoperative diagnosis of T2D, hypertension, dyslipidemia, cardiopathies (including arrhythmias, ischemic cardiopathy or congestive cardiac failure), strokes, Charlson index and analytical parameters of the lipid (triglycerids, total cholesterol and the subfractions High Density Lipoproteins (HDL-cholesterol) and Low Density Lipoproteins (LDL-cholesterol) and glycemic profile (fasting glucose and glycated hemoglobin). Cardiovascular risk factors, such as the Framingham risk score, were analyzed.
Primary outcomes were the appearance of medical and septic postoperative complications. Medical complications include cardiovascular complications (new onset or impairment of acute heart infarction, arrhythmias, cardiac failure or stroke), respiratory complications (pneumonia or respiratory failure) and acute renal failure. Septic complications include, urinary tract infections, incisional or organ/space surgical site infection (SSI), pneumonia or bacteriemia of other origin.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Bariatric surgery
Laparoscopic Roux-en-Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG), as primary bariatric procedures, were performed. \^Postoperative complications were assessed.
Eligibility Criteria
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Inclusion Criteria
* BMI \>35 Kg/m2 associated with obesity-related comorbidities
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Dr. Negrin University Hospital
OTHER
Hospital General Universitario Elche
OTHER
Responsible Party
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Jaime Ruiz-Tovar, MD, PhD
Clinical Professor
Principal Investigators
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Asuncion Acosta
Role: STUDY_DIRECTOR
Hospital Universitario Dr Negrin
Other Identifiers
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CEIC13-2
Identifier Type: -
Identifier Source: org_study_id