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Use of Seamguard to Prevent Leak and Bleeding in Gastrointestinal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01180140
Recruitment Status : Completed
First Posted : August 11, 2010
Last Update Posted : August 11, 2010
Sponsor:
Collaborators:
Unidad mixta de Investigación HUC-ULL
University of La Laguna
Information provided by:
Hospital Universitario de Canarias

Study Description
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Brief Summary:

The purpose of this study is to determinate the utility of staple-line reinforcement on lineal gastrointestinal anastomoses.

Hypothesis: Seamguard device will decrease the incidence of leak and bleeding in digestive lineal stapled anastomoses.


Condition or disease Intervention/treatment Phase
Leak on Lineal Stapled Anastomoses Bleeding on Lineal Stapled Anastomoses Device: Seamguard Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Use of Seamguard to Prevent Digestive Leak and Bleeding on Lineal Stapled Anastomoses: a Prospective Randomized Clinical Trial
Study Start Date : March 2006
Actual Primary Completion Date : August 2009
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
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Arm Intervention/treatment
No Intervention: 1
without seamguard
Experimental: 2
with seamguard
 Device: 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.


Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients who will need a lineal stapled anastomoses (colon cancer in cecum, for example)

Exclusion Criteria:

  • circular anastomoses
  • bariatric surgery
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180140


Locations
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Spain
Hospital Universitario de Canarias
La Laguna, Santa Cruz de Tenerife, Spain, 38320
Sponsors and Collaborators
Hospital Universitario de Canarias
Unidad mixta de Investigación HUC-ULL
University of La Laguna
More Information
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Responsible Party: Mª Cruz Correa Flores, HUC
ClinicalTrials.gov Identifier: NCT01180140    
Other Study ID Numbers: Seamguard Study
First Posted: August 11, 2010    Key Record Dates
Last Update Posted: August 11, 2010
Last Verified: August 2010
Keywords provided by Hospital Universitario de Canarias:
Seamguard
staple-line reinforcement
leak
bleeding
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes