Use of Seamguard to Prevent Leak and Bleeding in Gastrointestinal Surgery
NCT ID: NCT01180140
Last Updated: 2010-08-11
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
PHASE4
113 participants
INTERVENTIONAL
2006-03-31
2010-06-30
Brief Summary
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Hypothesis: Seamguard device will decrease the incidence of leak and bleeding in digestive lineal stapled anastomoses.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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1
without seamguard
No interventions assigned to this group
2
with seamguard
Seamguard
GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement is specifically engineered to reduce the incidence of perioperative leaks and bleeding in a variety of open and minimally invasive surgeries. Then, after six months, it is completely absorbed eliminating the risk of a prolonged inflammatory response.
Interventions
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Seamguard
GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement is specifically engineered to reduce the incidence of perioperative leaks and bleeding in a variety of open and minimally invasive surgeries. Then, after six months, it is completely absorbed eliminating the risk of a prolonged inflammatory response.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* bariatric surgery
18 Years
90 Years
ALL
No
Sponsors
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Unidad mixta de Investigación HUC-ULL
UNKNOWN
University of La Laguna
OTHER
Hospital Universitario de Canarias
OTHER
Responsible Party
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HUC
Locations
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Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain
Countries
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Other Identifiers
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Seamguard Study
Identifier Type: -
Identifier Source: org_study_id
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