Efficacy and Application of the Alfred SmartBag System After Ileostomy Creation in Colorectal Surgery: A Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Unplanned hospital readmission within 30 days of surgery
研究概览
简要总结
In this study 100 patients due to undergo surgery that will result in an ostomy will be provided with the Alfred SmartBag system. The system encompasses a pouch, a baseplate that can track the volumetric filling of the pouch through integrated thermistor and capacitive sensors and potential leakage and skin irritation development through integrated thermistors in the wafer.
While patients with ileostomy have a risk of dehydration, early identification of those at greater risk may lead to home intervention and decreasing hospital readmission. Decreased readmissions ultimately leads to faster post-operative recovery, decreased risk of complications associated with readmissions (e.i. nosocomial infection, pneumonia, etc.) and decreased healthcare costs. Also evaluating the patients for possible stoma related complications in real time will help in treating them in a timely manner.
详细描述
Sample size The number of subjects planned to enroll in the study is 100. It is plan to enroll 4 participants per month. Participants will be part of the study from the date of consent to the date when complete the follow-up at 90 days post-surgery.
Selection and screening of potential participants Patients scheduled for office visit with staff physician who will be undergoing to colorectal surgery with new ileostomy creation at the Cleveland Clinic, Main Campus.
Withdraws:
- Participants have the right to withdraw from the study at any time. Written request should be made to the Principal Investigator (PI) via mail. Emre Gorgun, MD, 9500 Euclid Ave. - A30. Cleveland, Oh. 44195
- Participants will be withdrawn from the study if become pregnant.
- Participants will be withdrawn from the study if any type of electronic implants is applied (i.e. pacemakers).
- Participant will be withdrawn per PI and/or sponsor request in the best interest of the participant (e.i. medical condition, technical problems with device or mobile app).
- Before withdrawn, participants will have the opportunity to contact nurse (care coordinator) to request information about changing Alfred SmartBag to regular ostomy bag at their own expense.
Research team:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 22 years of age.
- •Ability to communicate in spoken and written English.
- •Ability to provide informed consent.
- •Scheduled for colorectal surgery with creation of new ileostomy.
- •Access to smartphone with bluetooth technology to support mobile and web application.
排除标准
- •Pregnancy. Pregnancy test, standard of care, prior to surgery will be reviewed.
- •Wearing electronic implants such as pacemakers.
研究组 & 干预措施
SmartBag arm
The Alfred SmartBag System will be placed on the ostomy site during surgery. The system will be used to wirelessly monitor ostomy function in the hospital setting and the patient will otherwise receive the standard of care. At discharge the patient will continue to use the Alfred SmartBag System and ostomy function will be monitored by the research and clinical teams remotely.
If participant's output is (i) less than 50mL or greater than 1500mL per day or (ii) greater than 1200mL in two days; the mobile app will alert not only the participant but also the clinical staff (nurse).
Participants will also receive support from a 'Patient Coach', a trained health coach who is also an ostomy patient to provide quality of life support.
干预措施: Alfred SmartBag (Device)
结局指标
主要结局
Unplanned hospital readmission within 30 days of surgery
时间窗: 30 days
Unplanned hospital readmission will be determined from the hospital patient record. This will be checked by the research team on the 30th postoperative day.
次要结局
- The incidence of high or low output stoma (output <50ml for 1 day, output >1500ml for 1 day or for >1200ml for 2 consecutive days within 30, 60 and 90 days of surgery(30, 60 and 90 days)
- The incidence of patient-reported stoma accidents (leakage) within 30, 60 and 90 days of surgery(30, 60 and 90 days)
- Patient reported satisfaction when using the Alfred SmartBag System(30, 60 and 90 days)
- Unplanned hospital readmission within 60 and 90 days of surgery(60 and 90 days)
- Hydration Clinic visits within 30, 60 and 90 days of surgery(30, 60 and 90 days)
- Surgical Site Infection rates within 30, 60 and 90 days of surgery(30, 60 and 90 days)
- Number of clinically significant dehydration events within 30, 60 and 90 days of surgery(30, 60 and 90 days)
- Emergency department visits within 30, 60 and 90 days of surgery(30, 60 and 90 days)
- Patient reported quality of life when using the Alfred SmartBag System(30, 60 and 90 days)