Bladder cancer
Conditions
Interventions
Trial group:Each subject was successively treated with a concave chassis and a flat chassis, each lasting for one stage (one stage was 2 weeks, approximately 14+/-4 days). Random grouping: In this stu
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-70 years, able to cooperate with follow-up; 2. Patients at least two months post-stoma surgery; 3. Peristomal body contour protrudes relative to other abdominal areas, forming a bulge with diameter approximately 6-30 cm and height >=2 cm; 4. Currently using flat baseplates with stoma leakage frequency >=1 time per week.
Exclusion criteria
Exclusion criteria: 1. Pre-existing peristomal skin lesions, such as infection or dermatitis; 2. Unable to change baseplates independently or with caregiver assistance; 3. Received radiotherapy or chemotherapy within two months; 4. Pregnant or lactating women, or patients with known allergies to ostomy products; 5. Require reoperation due to any disease-related reasons after stoma surgery; 6. Underlying conditions (such as diabetes, chronic obstructive pulmonary disease, hypertension, cerebral infarction, coronary heart disease, etc.) or psychiatric disorders not effectively controlled, judged by the investigator as unsuitable for participation in this trial; 7. Participated in other medical device clinical trials within one month prior to screening; 8. Unable to cooperate with the study due to various subjective or objective factors from the patient or family members.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stoma appliance fit;Peristomal skin condition and incidence of skin complications; | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency and severity of leakage;Appliance change frequency;Comfort score;Quality of life;Ostomy Leakage Impact Tool (OLIT); | — |
Countries
China
Contacts
Public ContactChe Xinyan
Peking University First Hospital
Outcome results
None listed