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临床试验/NCT04683666
NCT04683666已完成不适用

Cardiovascular Risk Factors of Medical and Septic Complications After Laparoscopic Bariatric Surgery. A Prospective Cohort Study

Hospital General Universitario Elche0 个研究点目标入组 177 人开始时间: 2013年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
177
主要终点
Medical complications

研究概览

简要总结

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.

详细描述

This study aimed to identify potential cardiovascular risk factors for postoperative medical and septic complications after bariatric surgery.

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI >40 Kg/m2
  • BMI >35 Kg/m2 associated with obesity-related comorbidities

排除标准

  • 未提供

结局指标

主要结局

Medical complications

时间窗: 90 days after surgery

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

时间窗: 90 days after surgery

Septic complications include, urinary tract infections, incisional or organ/space surgical site infection (SSI), pneumonia or bacteriemia of other origin.

次要结局

未报告次要终点

研究者

发起方
Hospital General Universitario Elche
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jaime Ruiz-Tovar, MD, PhD

Clinical Professor

Hospital General Universitario Elche

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