Perineal Reconstruction Following eLAPE and Simultaneous Stoma Sublay Reinforcement
NCT ID: NCT01670851
Last Updated: 2015-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
20 participants
OBSERVATIONAL
2013-03-31
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Strattice
eLAPE
Strattice
Perineal reconstruction and stoma reinforcement with Strattice
Interventions
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Strattice
Perineal reconstruction and stoma reinforcement with Strattice
Eligibility Criteria
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Inclusion Criteria
* Life expectancy \> 2 yrs
* Neoadjuvant radiotherapy with or without chemotherapy
Exclusion Criteria
* Previously irradiated patients (i.e. radiation therapy for a previous cancer)
* Co-morbidities of: systemic infection, chronic liver failure, chronic renal failure, HIV, Hepatitis C, other advanced/metastatic cancer, collagen disorder
* sensitivity to porcine derived products or polysorbate
18 Years
ALL
No
Sponsors
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Karolinska University Hospital
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Slagelse Hospital
OTHER
University Hospitals, Leicester
OTHER
Responsible Party
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Principal Investigators
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Baljit Singh, FRCS, FACS
Role: PRINCIPAL_INVESTIGATOR
University Hospital Leicester, UK
Sanjay Chaudhri, FRCS
Role: PRINCIPAL_INVESTIGATOR
University Hospital Leicester, UK
Per J Nilsson, MD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Pierre J Maina, MD
Role: PRINCIPAL_INVESTIGATOR
Slagelse Hospital, Denmark
W Bemelman, MD
Role: PRINCIPAL_INVESTIGATOR
Academic Medical Center, Amsterdam, Netherlands
Locations
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Slagelse Hospital
Slagelse, , Denmark
Karolinska University Hospital
Stockholm, , Sweden
University Hospitals Leicester
Leicester, , United Kingdom
Countries
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Other Identifiers
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ISIS.11.01.06.BS/SC
Identifier Type: -
Identifier Source: org_study_id