Attachment, Ileostomy, colostomy, Leakage, Feces, Skin irritation, stoma care, stomacare nurse, stoma related morbidity, costs
Conditions
Interventions
We intend to investigate the costs and effectiveness of a new, uniform ostomy care pathway (the “I-aid”) to improve the quality of care and quality of life of patients who will receive an ostomy. The
Sponsors
Academic Medical Center Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: 1. All patients who receive a planned end or loop colo- or ileostomy; 2. Age between 18 and 85 years; 3. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Life expectancy of less than one year; 2. BMI > 35 or < 18; 3. Emergency surgery; 4. ASA IV; 5. Insufficient command of the Dutch language or cognitively unable to complete Dutch questionnaires; 6. Dementia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The percentage of patients with one or more stoma-related complications occurring within three months after receiving the ostomy. This time interval is chosen because within this period the stoma reaches its final shape and the vast majority of complications occurs. Stoma-related complications are: peristomal leakage, skin irritation, stomal dehiscence, retraction, protrusion, or stenosis, infection, and hemorrhage, according to standard predefined criteria; 2. Patients’ quality of life, measured by means of the validated Stoma-Qol questionnaire (Prieto 2005), consisting of 20 items scored on a 4-point scale, and the EQ-5D to enable calculation of QALYs. These parameters will be assessed before surgery and 1 and 3 months after receiving the stoma. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number and costs during the follow-up period of used stoma materials, outpatient visits, readmissions, the personnel involved, as well as the out-of-pocket expenses by patients. | — |
Contacts
Public ContactM.F. Sier
Meibergdreef 9
Outcome results
None listed