The I-aid: A new care pathway to improve quality of care and quality of life in ileostomy and colostomy patients”.
Recruiting
- Conditions
- Attachment, Ileostomy, colostomy, Leakage, Feces, Skin irritation, stoma care, stomacare nurse, stoma related morbidity, costs
- Registration Number
- NL-OMON21143
- Lead Sponsor
- Academic Medical Center Amsterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 210
Inclusion Criteria
1. All patients who receive a planned end or loop colo- or ileostomy;
2. Age between 18 and 85 years;
Exclusion Criteria
1. Life expectancy of less than one year;
2. BMI > 35 or < 18;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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;<br /><br>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 Outcome Measures
Name Time Method umber 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.