ANTERO-5: A Clinical Investigation of Gastric Motility in Adult Patients at Risk to Develop Postoperative Ileus Following Colorectal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Feasibility (composite endpoint)
研究概览
简要总结
A monocenter, non-randomized interventional investigation in 3 panels of adult patients undergoing elective colorectal surgery who are at risk to develop postoperative ileus.
The feasibility to use the VIPUN Gastric Monitoring System prototype 0.3 will be explored in this population for the first time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 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
- •Signed Informed Consent
- •At least 18 years old
- •BMI between and including 18 and 30
- •Understand and able to read Dutch
- •Planned to undergo elective colorectal surgery
排除标准
- •Known history of documented gastroparesis
- •Known history of functional dyspepsia
- •Known / suspected current use of illicit drugs
- •Known psychiatric or neurological illness
- •Any prior gastrointestinal surgery that could influence normal gastric function in the opinion of the investigator
- •Known history of heart or vascular diseases like irregular heartbeats, angina or heart attack
- •Nasopharyngeal surgery in the last 30 days
- •Suspected basal skull fracture or severe maxillofacial trauma
- •Known history of thermal or chemical injury to upper respiratory tract or esophagus
- •Current esophageal or nasopharyngeal obstruction
- •Known coagulopathy
- •Known esophageal varices
研究组 & 干预措施
Panel 1 - High risk for postoperative ileus
Intervention in patients at high risk to develop prolonged postoperative ileus. Monitoring postoperative gastric motility for 2 consecutive days in patients who require preventive placement of a nasogastric feeding tube due to a high risk to develop postoperative ileus. Allowing to explore associations between gastric motility and general clinical evolution.
干预措施: Panel 1 - High risk for postoperative ileus (VIPUN Gastric Monitoring System) (Device)
Panel 2 - Postoperative ileus arm with investigational device
Intervention in a population of patients with clinical signs of postoperative ileus, requiring a nasogastric feeding tube for symptom relief. The investigational medical device will be applied. Allowing to explore the association of gastric motility and clinical signs of postoperative ileus in an enriched population with true postoperative ileus.
干预措施: Panel 2 - Postoperative ileus arm with investigational device (VIPUN Gastric Monitoring System) (Device)
Panel 3 - Postoperative ileus arm with standard of care
Standard of care control group of patients with clinical signs of postoperative ileus requiring a standard nasogastric feeding tube for symptom relief. Symptoms will be surveyed as control group to assess safety and tolerability of the investigational medical device.
结局指标
主要结局
Feasibility (composite endpoint)
时间窗: Day 1 - Day 14
Composite endpoint comprising: procedural success (absence of protocol deviations with regard to motility measurement), tolerability of the device (non-validated questionnaire on nasopharyngeal discomfort and the incidence of intolerance resulting in early removal of the investigational device) and device-related safety (incidence of adverse device effects related to the use of the device).
次要结局
- Evolution postoperative ileus - staff reported(Day 1 until completion study procedures (maximum 14 days).)
- In hospital quality of life (EQ-5D-3L questionnaire)(Day 1 until completion study procedures (maximum 14 days))
- Abdominal bloating severity(Day 1 until completion study procedures (maximum 14 days))
- Abdominal pain severity(Day 1 until completion study procedures (maximum 14 days))
- Abdominal discomfort severity(Day 1 until completion study procedures (maximum 14 days))
- Gastric motility(Day 1 until termination motility recording (maximum 48 hours))
- Nausea severity(Day 1 until completion study procedures (maximum 14 days))
- Device performance(Day 1 until removal of device, no later than Day 14)