Transition to Ambulatory Bariatric Surgery (TABS) Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Emergency Department Visits
研究概览
简要总结
This study will compare same day discharge and at least one night stay in the hospital after bariatric surgery. Patients undergoing bariatric surgery will be randomized (i.e. have an equal chance of either plan) to either group. The study's primary outcome is the frequency patients in the study require a visit to the emergency room within 7 days of their surgery.
详细描述
This pragmatic, parallel, randomized, open-label trial aims to determine the safety and feasibility of same day discharge (SDD) for bariatric surgery including sleeve gastrectomy and gastric bypass. Investigators will investigate the frequency of 7-day emergency department visits with SDD after bariatric surgery (Aim 1). In addition, the investigators will compare total 30-day charges between participants who undergo same day discharge versus those receive post-operative hospital admission (Aim 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI ≤ 60 kg/m2
- •Primary Sleeve gastrectomy or Gastric Bypass,
- •Undergoing bariatric surgery at sponsor site
排除标准
- •Type 1 Diabetes
- •Myocardial Infarction
- •Unstable Angina or Heart Failure
- •Prior Stroke
- •Solid organ transplantation
- •Systemic glucocorticoid prior 28 days
- •Severe Obstructive Sleep Apnea
- •Uncontrolled Hypertension (Systolic > 150, Diastolic > 90)
- •Untreated Hyperthyroidism
- •Chronic Kidney Disease (EGFR < 60)
- •Current anticoagulant use,
- •Poorly controlled Type 2 diabetes (Hemoglobin A1c in last 3 months > 8.5%)
- •Chronic opioid use
- •Insulin dependence.
- •Need for extended venous thromboembolic event prophylaxis,
- •> 1 lifetime bariatric surgery (revisional or conversion bariatric surgery)
- •Patient lives > 130 miles from the hospital.
- •Tobacco use in last 12 months
- •Desire to become pregnant or active pregnancy
- •Prisoners
- •Unable or unwilling to follow-up
- •Unable to understand or provide consent
研究组 & 干预措施
Same Day Discharge
Patients in the same day discharge will be discharged from the hospital following surgery without an overnight stay in the hospital.
干预措施: Same Day Discharge (Other)
Standard of care - Hospital Admission
Patients in the standard of care arm will be admitted to the hospital for at least one overnight stay in the hospital.
结局指标
主要结局
Emergency Department Visits
时间窗: baseline to seven days
Number of emergency room visits after surgery
次要结局
- Readmissions to the hospital(baseline to 30 days)
- The number of operations or procedures(baseline to 30 days)
研究者
Jason Samuels
Principal Investigator
Vanderbilt University Medical Center