Trials / Completed
CompletedNCT01670851
Perineal Reconstruction Following eLAPE and Simultaneous Stoma Sublay Reinforcement
Perineal Reconstruction Following Extralevator Abdominoperineal Excision of Rectum and Simultaneous Stoma Sublay Reinforcement
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 20 (actual)
- Sponsor
- University Hospitals, Leicester · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, multicenter, single arm, observational pilot study to assess the clinical outcomes of Strattice Reconstructive Tissue Matrix for perineal reconstruction following eLAPE and simultaneous stoma reinforcement.
Detailed description
About 40 subjects will be enrolled from 4 centers over approx 24 months. Subjects will all be undergoing extralevator abdominoperineal excision with concomitant ostomy creation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Strattice | Perineal reconstruction and stoma reinforcement with Strattice |
Timeline
- Start date
- 2013-03-01
- Primary completion
- 2015-09-01
- Completion
- 2015-09-01
- First posted
- 2012-08-22
- Last updated
- 2015-12-08
Locations
3 sites across 3 countries: Denmark, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT01670851. Inclusion in this directory is not an endorsement.