Enterocutaneous fistula repair using the Biodesign enterocutaneous fistula plug ( Cook Medical)
- Conditions
- abnormal connection between gut and skinEnterocutaneous fistula10017990
- Registration Number
- NL-OMON38559
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
A longstanding ( more than 6 months ) therapy-resistant ( therapy according to AVL standard) low-output ( less than 200 ml/ 24 hours) ECF.
Size of the ECF : 2/6-mm diameter, length less than 18 cm.
Exclusion Criteria
Sensitivity to porcine materials.
An abscess cavity that is not sufficiently drained
An abscess cavity that is immediately adjacent to the internal fistula opening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Technical feasibility of the treatment protocol, including: to determine the<br /><br>feasibility, tolerance and primary technical success rate of the<br /><br>Enterocutaneous fistula repair using the Biodesign enterocutaneous fistula plug<br /><br>( Cook Medical)</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objective will be to evaluate the longterm success ( after 3, 6<br /><br>and 12 months): permanent closure ( non-production, skin healing) of the<br /><br>fistula.</p><br>