Homocysteine After Laparoscopic Roux-enY Gastric Bypass: a Comprehensive Evalutation in 708 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 708
- 试验地点
- 1
- 主要终点
- Homocysteine in µmol/l assessed by CMIA technique.
研究概览
简要总结
Changes in homocysteine values after bariatric surgery remain controversially discussed. This is the first comprehensive summary to depict timeline changes in homocysteine levels following laparoscopic roux-en-Y gastric bypass.
详细描述
Homocysteine is an independent risk factor for cardiovascular disease. Changes in homocysteine levels following bariatric surgery remain controversially discussed.
708 consecutive patients underwent laparoscopic roux-en-Y gastric bypass over a 6 year period. Throughout their routine follow-up, demographic data as well as homocysteine, folate and vitamin B12 were retrospectively collected at the timepoints: preoperatively, at 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, and 96 months postoperatively.
In order to reveal clinical relevance of the results, patients were sent a special questionnaire accompanied by an informed consent form for participation and asked for cardiovascular disease events (myocardial infarction, stroke, deep venous thrombosis) or any other hospital stay after the surgery and cross checked with two region wide databases which account for approx. 80% of all hospital contacts in the region. Additionally, the database was networked with the statewide death registry in order to reveal deceased subjects and data about their demise through the beforementioned databases was collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI > 40kg/m2 or BMI > 35 kg/m2 including relevant comorbidities
- •Age between 18 to 75 years
- •suitable for operation, consent
- •no contraindications for the operation
排除标准
- •BMI < 35 kg/m2
- •age below 18 or above 75 years
- •not able to consent to the operation
- •severe medical conditions not applicable for general anaesthesia
- •non compliance
结局指标
主要结局
Homocysteine in µmol/l assessed by CMIA technique.
时间窗: timepoints: preoperatively, 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, and 96 months postoperatively
Measured by Chemiluminescent microparticle immunoassay (CMIA) technique in µmol/l. Change of homocysteine over the timeframe at the timepoints: preoperatively, 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, and 96 months postoperatively.
次要结局
- Folate in nmol/l assessed by ELCIA method.(timepoints: preoperatively, 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, and 96 months postoperatively)
- Vitamin B12 in pmol/l assessed by CMIA technique.(timepoints: preoperatively, 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, and 96 months postoperatively)
- Weight in kg measured by a standard scale.(timepoints: preoperatively, 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, and 96 months postoperatively)
- Number of cardiovascular events assessed by a questionnaire and cross checking with 2 state wide databases.(Through study attendance the specific date of the incident was assessed and assigned to the timepoints: preoperatively, 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, and 96 months postoperatively)
研究者
Gerhard Prager
associate professor, MD
Medical University of Vienna