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Use of Seamguard to Prevent Leak and Bleeding in Gastrointestinal Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01180140
First Posted: August 11, 2010
Last Update Posted: August 11, 2010
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.
Collaborators:
Unidad mixta de Investigación HUC-ULL
University of La Laguna
Information provided by:
Hospital Universitario de Canarias
  Purpose

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 Intervention Phase
Leak on Lineal Stapled Anastomoses Bleeding on Lineal Stapled Anastomoses Device: Seamguard Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hospital Universitario de Canarias:

Enrollment: 113
Study Start Date: March 2006
Study Completion Date: June 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
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
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
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

Responsible Party: Mª Cruz Correa Flores, HUC
ClinicalTrials.gov Identifier: NCT01180140     History of Changes
Other Study ID Numbers: Seamguard Study
First Submitted: July 18, 2010
First Posted: August 11, 2010
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:
Hemorrhage
Pathologic Processes