Intracutaneously versus transcutaneously sutured ileostomy: A randomized multicenter trial (ISI trial)
Completed
- Conditions
- artificial opening of the small intestineileostomy100149821002445010017998
- Registration Number
- NL-OMON34429
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 300
Inclusion Criteria
- All patients who receive an end or loop ileostomy
- Age between 18 and 80 years
- Written informed consent
Exclusion Criteria
- Life expectancy of less than one year
- BMI > 35 or < 18
- Emergency surgery
- ASA IV
- Insufficient command of the Dutch language or cognitively unable to complete Dutch questionnaires.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p> Leakage of feces under the stoma plaque and peristomal dermatitis around the<br /><br>stitiches or due to leakage of feces</p><br>
- Secondary Outcome Measures
Name Time Method <p>Quality of life, as measured by the Stoma-Qol<br /><br>Stoma-related morbidity<br /><br>Cost analysis (Stoma materials and outpatient visits)</p><br>