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临床试验/NCT04635215
NCT04635215已完成不适用

Observational Study of the Quality of Life of Patients With New Stoma Formation and Users of a Stoma Appliance From the SenSura Mio Range With Bodyfit® Technology

Laboratoires Coloplast S.A.S73 个研究点 分布在 1 个国家目标入组 195 人开始时间: 2019年2月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
195
试验地点
73
主要终点
Stoma QoL score at 3 months

研究概览

简要总结

An ostomy is defined by the connection of a viscera to the skin, outside its natural location, by diversion from the digestive or urinary tract. The bodily injury, i.e. the creation of a stoma, has familiar, social and professional consequences. Personalized care, with the help of an ostomy nurse, is essential to accompany the ostomy patient in the changes of his or her life habits. In addition, the progress made in the various appliances, pouching and irrigation systems, contribute to improving the quality of life of these people.

In this context of adapted support, COLOPLAST has developed a range of ostomy pouches, the SenSura Mio BodyFit® technology range, for digestive or urinary stomas. The diversity of the devices makes it possible to find the most suitable combination to adapt to the morphology thanks to an elastic adhesive for a secure fit to individual body shape, and the textile materials used make it possible to optimize wearing comfort.

The aim of this study is to evaluate the quality of life of patients with recent ostomies with one of COLOPLAST's SenSura Mio devices at three months after discharge from the hospital. The condition of the skin around the stoma and the level of satisfaction of the patients will also be evaluated. Finally, the results obtained aim to identify factors predictive of a better quality of life in order to improve management.

详细描述

Today, there are about 80,000 people with ostomies in France and 19,000 ostomies are created each year.

An ostomy is defined by a viscera reaching the skin, outside its natural location, by diversion of the digestive (enterostomy) or urinary (ureterostomy) tract. Digestive ostomies are temporary or permanent palliative surgeries that consist of connecting a segment of the healthy digestive tract to the surface of the skin, either downstream or upstream of a lesion. There are several reasons for this type of stoma: following colorectal cancer or IBD (chronic inflammatory bowel disease), or to decompress and drain the digestive tract in occlusion, or to protect a digestive anastomosis by temporarily diverting the intestinal flow. Urinary ostomies are usually performed following bladder cancer or neurogenic bladder that has resulted in the removal of the bladderr. The urinary tract is then diverted to allow the evacuation of urine into an artificial pouch.

The bodily injury, the creation of a stoma, can have serious familiar, social and professional repercussions. An early follow-up from the preoperative phase and long-term technical and psychological support promote an adaptation of quality. Helping the patient to live well with his disability is a complex task that mobilizes the skills of a multidisciplinary team of caregivers. Mastery of surgical techniques for the creation of ostomies and close collaboration between the surgeon and the stoma therapist are essential for the personalized care of ostomy patients.

Advances in various devices, bag systems and irrigation systems are concrete means that contribute greatly to improving the patient's quality of life. In this context of technological advances, COLOPLAST has developed a range of devices for incontinent digestive and urinary stomas, SenSura Mio Technology BodyFit®. This range of pouches adapts to peristomal morphology and body movements due to an elastic adhesive for a secure fit to individual body shapes. In addition, the pouches are designed to remain discreet and maximize wearing comfort due to a neutral-grey color water-repellent textile material, invisible even under white clothing, and a full-circle prefilter to differ filter saturation for proven reduction of ballooning.

The objective of this study is to evaluate the use of SenSura Mio products in real-life conditions in patients with recent ostomies. For this purpose, we will use the Stoma-QoL specific quality of life scale, as well as the Peristomal Skin Condition Rating Scale (DET Score).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Stoma QoL score at 3 months

时间窗: The primary outcome will be measured at 3 months

The Stoma-QOL questionnaire has 20 questions covering 4 domains,: sleep, intimate relationships, relationships with family and close friends, and social relationships with other people. For each question, the answer ranges from 1 (always) to 4 (never). The points obtained for each of the 20 questions are added together to obtain an overall score. This raw summary score per patient in the 20-80 range will be converted into a final "0-100 score" where 0 indicates the worst Quality of Life and 100 the best Quality of Life. A table is available for converting raw scores into final scores.

次要结局

  • Stoma QoL score at 1 and 2 months(At 1 and 2 months)
  • DET Score(At 1, 2 and 3 months)
  • Patient satisfaction(3 months)

研究者

发起方
Laboratoires Coloplast S.A.S
申办方类型
Industry
责任方
Sponsor

研究点 (73)

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