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Use of Seamguard to Prevent Leak and Bleeding in Gastrointestinal Surgery

This study has been completed.
Unidad mixta de Investigación HUC-ULL
University of La Laguna
Information provided by:
Hospital Universitario de Canarias Identifier:
First received: July 18, 2010
Last updated: August 10, 2010
Last verified: August 2010

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 Blind (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.


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

Inclusion Criteria:

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

Exclusion Criteria:

  • circular anastomoses
  • bariatric surgery
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Please refer to this study by its identifier: NCT01180140

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 Identifier: NCT01180140     History of Changes
Other Study ID Numbers: Seamguard Study
Study First Received: July 18, 2010
Last Updated: August 10, 2010

Keywords provided by Hospital Universitario de Canarias:
staple-line reinforcement

Additional relevant MeSH terms:
Pathologic Processes processed this record on July 24, 2017