Bariatric Outcomes Longitudinal Database (BOLD)
试验速览
- 阶段
- 不适用
- 入组人数
- 600,000
- 试验地点
- 1
- 主要终点
- Improvement of comorbidities
研究概览
简要总结
The primary purpose of the Bariatric Outcomes Longitudinal Database (BOLD) study is to assess the mid- and long-term outcomes of bariatric surgeries and to analyze the relationship between these outcomes and 1) patient demographics and comorbidities, 2) clinical and surgical characteristics, and 3) pre-operative, peri-operative and post-operative care and treatment.
详细描述
Participants in the BOLD study include all patients who 1) have their bariatric surgery performed by either a Participant in the American Society for Metabolic and Bariatric Surgery designated Bariatric Surgery Center of Excellence or by a Fellow of the American Society for Metabolic and Bariatric Surgery 2) have been provided with a copy of the BOLD Patient Information Sheet. Patients under 18 years of age are included if a copy of the Patient Information Sheet is provided to an authorized legal representative.
The Patient Information Sheet containing information pertaining to the BOLD study is provided to the patient at the first pre-operative visit. The patient is not required to sign a consent form to participate in the study but must let the bariatric surgeon staff know if he/she does not wish to participate.
The following information will be collected for every bariatric surgery patient:
- Personal information: gender, race, employment status, insurance status, medical record number, year of birth, height, weight and prior surgeries. The surgeon has the option of entering patient name for internal tracking purposes.
- Information about surgery: date of admission, date of surgery and date of discharge.
- Information about medical condition before, during and after surgery.
Patient information is entered into BOLD through a secure website and permanently stored in a database that is managed by Surgical Review Corporation (SRC). This database is secure and meets the requirements for the protection of patient confidentiality as required by the Health Insurance Portability and Accountability Act (HIPAA).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bariatric surgery patients
- •Males and Females
- •All races
排除标准
- •Negative psychological evaluation
- •Surgeon's evaluation that patient is not a candidate for surgery
结局指标
主要结局
Improvement of comorbidities
时间窗: Within 1 year
次要结局
- Mortality, weight loss, surgical complications(Within 1 year)
