Postbariatric EArly Discharge Controlled by Healthdot (PEACH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 208
- 试验地点
- 2
- 主要终点
- Readmission (at least one night in hospital)
研究概览
简要总结
This clinical investigation is a single center patient preference trial in a tertiary hospital in the Netherlands, designed to compare the outcome of two different recovery paths after standard of care bariatric surgery. The difference between both recovery paths is that half of the patients will get the standard of care by staying one night in the hospital before returning home (group B), while the other half will receive a Healthdot directly after surgery and leave the hospital on the same day (evening) (group A). 200 patients will be recruited and can choose whether they want to be assigned to the the regular recovery path or receive a Healthdot and leave the hospital on the same day. If they have no preference they will be randomly assigned to one of the two groups. Patients in the outpatient recovery group will wear the Healthdot for 7 days at home and vital signs (heart rate and respiratory rate, together with context data on activity and posture) will be transmitted to the hospital to monitor recovery. The study is mainly designed to investigate if the clinical outcome in both groups is equal (non-inferiority) based on a combined outcome measures like 30 days readmission rate and patient satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (equal or above 18)
- •Approval for primary bariatric surgery (gastric sleeve or bypass) by a multidisciplinary bariatric team
- •Willing and able to sign informed consent form
- •Able to understand instructions
- •In possession of a telephone on which patient can be reached for the duration of participation (day 1-8)
- •An adult person must be present at the same location as the patient during the first night following surgery who is able to mobilize help or seek medical care if necessary.
排除标准
- •Patients of psychiatric wards, inmates of prisons, or other state institutions
- •Investigator or any other team member involved directly or indirectly in the conduct of the clinical study
- •Any skin condition, for example prior rash, discoloration, scars or open wounds at the area (Left lower rib) where the Healthdot needs to be placed
- •Known allergy for the tissue adhesive used in the Healthdot (white band-aid)
- •Use of topical that is known to influence the skin at the test area (such as medical and non-medical creams or lotions)
- •Patient with active implantables such as Implantable Cardioverter Defibrilator (ICD) and pacemaker
- •Expected participation less than 8 days
- •Left lower rib (place where Healthdot will be applied) is involved in the area of surgery, area of disinfection or area where bandages are needed.
- •Patients with antibiotic resitant infections (e.g. MRSA)
结局指标
主要结局
Readmission (at least one night in hospital)
时间窗: Within 30 days after primary surgery
Readmission will be determined from the patient medical record
Mortality
时间窗: Within 30 days after primary surgery
Mortality will be determined from the patient medical record
Severe postoperative complications (Clavien-Dindo IIIb or higher)
时间窗: Within 30 days after primary surgery
Severe postoperative complications will be determined from the patient medical record
Prolonged length of stay (3 days or more in hospital)
时间窗: Within 30 days after primary surgery
Prolonged length of stay will be determined from the patient medical record
Mild complications (Clavien-Dindo II and IIIa)
时间窗: Within 30 days after primary surgery
Mild complications will be determined from the patient medical record
次要结局
未报告次要终点