HydrustomaC3 - Randomized Clinical Trial to Evaluate Safety and Efficacy of Innovative Medical Devices for Colostomy Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hydrumedical
- 入组人数
- 45
- 试验地点
- 12
- 主要终点
- Adverse effects
研究概览
简要总结
The surgical ostomy process happens when it is necessary to open an organ (such as the intestine) in order to maintain a communication channel with the external environment. The need for ostomy surgery can happen as a result of illness, genetic factors, or trauma. Despite the extensive improvements in colorectal surgery, in case there is a need for total or partial extraction and exteriorization of the large intestine (colostomy), it is often necessary to perform a stoma that connects the end of the preserved intestine to the skin, in which cases it is necessary to place a a colostomy bag for stool collection. Thus, there is a substantial number of patients who need to live with a permanent abdominal stoma that significantly affects their quality of life, implying significant changes, both physical and social. It will then be necessary for patients to adjust their daily routines in order to deal with stoma care.
The primary objective of this study is to evaluate the Hydrustoma C3 medical devices (plate C3, capsule C3, night bag C3) in terms of its efficacy and safety as colostomy devices. It is also a primary objective of this study to compare the health-related quality of life in patients with colostomy when using a control and Hydrustoma C3 devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent;
- •Male and Female patients;
- •Adult aged ≥ 18;
- •Descending and sigmoid colostomy created more than 3 months previously to the beginning of the study;
- •Having formed stool and using a flat ostomy appliance;
- •Able to understand the study procedures and fill questionaries;
- •Able to apply and remove the ostomy device autonomously.
排除标准
- •Repeated experiences of leakage with the usual ostomy device,
- •Chronically liquid stools,
- •Peristomal skin disorders,
- •Known allergic reactions to components of the device,
- •Receiving chemotherapy, radiation therapy or steroids in the previous month
结局指标
主要结局
Adverse effects
时间窗: 14 days
Safety evaluations will be done by monitoring adverse events.
Efficacy of the device (journal of capsule/bag changes)
时间窗: 14 days
Efficacy will be accessed by asking patients to record on a journal/diary, for each capsule/bag change, what was the reason for the change, and the occurrence and level of leakage.
Quality of life of the participant (Stoma Quality of Life questionnaire)
时间窗: 14 days
In order to compare stoma related quality of life in patients with colostomy when using a control device and the Hydrustoma C3 devices the Stoma Quality of Life questionnaire will be used. This questionnaire is composed of 20 questions. Example of question "I worry that the bag detaches.". All questions must be answered on a scale of 1 to 4, being 1 always and 4 never.
Safety of the device (Discolouration, Erosion, Tissue overgrowth score)
时间窗: 14 days
Safety evaluations will be done by monitoring the peristomal skin using the validated Ostomy Skin tool (DET score). The DET Score is calculated by examining the peristomal skin and evaluate the skin based on the descriptions in each of the 3 domains, discolouration (D), erosion (E) and tissue overgrowth (T); and assessing the size of the area affected in each of the 3 domains. The total score is (maximum 15) calculated by adding all of the subscores from each domain together.
次要结局
- Satisfaction of the participant (questionnaire)(14 days)