CLOUDS-Study: Cross-sectional investigation of burden of disease in newly operated stoma patients

Coloplast UK & Ireland Ltd0 个研究点目标入组 117 人开始时间: 2022年2月4日最近更新: 2024年9月9日

适应症

试验速览

暂无简介。

•1. Have given written informed consent
•2. Be at least 18 years of age and have full legal capacity
•3. Have had their stoma for less than 12 months
•4. Ileo- or colostomists with liquid and/or mushy output (Bristol scale type 5-7)
•5. Have intact skin on the peristomal area (assessed by investigator)
•6. Have been self-managing stoma appliance for at least 14 days.
•7. Must be able to complete the online survey via the EDC system

•1. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tab-let/injection) treatment.
•2. Have previously participated in this investiga-tion.
•3. Patients with a complicated stoma at baseline (dehiscence/prolapse/hernia)
•4. Having more than one abdominal stoma simul-taneously present.
•5. Ongoing non-healed abdominal wounds
•6. Reoperation / stoma reversal planned prior to completion of first study visit or questionnaire assessments.
•7. Limited life expectancy / palliative care patients
•8. Stage 4 cancer patients
•9. Enrolment into an interventional stoma/stoma device trial within the last 12 months

发起方

Coloplast UK & Ireland Ltd