NCT05259111已完成不适用
Acute Care at Home for Adults Undergoing Bariatric Sleeve Gastrectomy: A Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Length of Stay
研究概览
简要总结
Providing acute care at home for medicine patients is a well-studied care model. Providing acute care at home immediately following major surgery is less well understood. The investigators seek to demonstrate the noninferiority of care at home versus the hospital for patients undergoing bariatric sleeve gastrectomy.
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
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All existing home hospital criteria apply, with the following taking precedent for this specific condition
- •21-55 years old
- •Indication for bariatric laparoscopic sleeve gastrectomy per surgeon
- •Caregiver capable of communicating with the home hospital team and able to stay in the same home as the patient the first night the patient is home
排除标准
- •All existing home hospital criteria apply, with the following taking precedent for this specific condition
- •Comorbidities
- •Body mass index>55
- •Chronic kidney disease
- •Heart failure
- •History of
- •Chronic pain (with or without opioid use)
- •Substance use disorder
- •Venous thromboembolism
- •Chronic headache
- •Medications
- •Anticoagulants and anti-platelets: aspirin, clopidogrel, warfarin, and direct oral anticoagulants
- •Beta blockade
- •Immunosuppressive
- •Supplemental oxygen
- •Allergy to ketorolac
- •Prolonged QTc
研究组 & 干预措施
Control, Care in the Hospital
No Intervention
After bariatric sleeve gastrectomy, patients receive their care in the hospital, as usual.
Intervention, Care in the Home
Experimental
After bariatric sleeve gastrectomy, patients receive their care in the home.
干预措施: Home hospital (Other)
结局指标
主要结局
Length of Stay
时间窗: From day of admission to day of discharge, assessed up to 10 months
Days spent hospitalized
次要结局
- Cost, direct(From day of admission to day of discharge, assessed up to 10 months)
- Opioid use(From day of admission to day of discharge, assessed up to 10 months)
- Motion(From day of admission to day of discharge, assessed up to 10 months)
研究者
David Levine
Associate Physician
Brigham and Women's Hospital
研究点 (2)
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