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Use of Seamguard to Prevent Leak and Bleeding in Gastrointestinal Surgery

This study has been completed.
Sponsor:
Collaborators:
Unidad mixta de Investigación HUC-ULL
Universidad de La Laguna
Information provided by:
Hospital Universitario de Canarias
ClinicalTrials.gov Identifier:
NCT01180140
First received: July 18, 2010
Last updated: August 10, 2010
Last verified: August 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Use of Seamguard to Prevent Digestive Leak and Bleeding on Lineal Stapled Anastomoses: a Prospective Randomized Clinical Trial

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Universidad de La Laguna
  More Information

No publications provided

Responsible Party: Mª Cruz Correa Flores, HUC
ClinicalTrials.gov Identifier: NCT01180140     History of Changes
Other Study ID Numbers: Seamguard Study
Study First Received: July 18, 2010
Last Updated: August 10, 2010
Health Authority: Spain: Comité Ético de Investigación Clínica

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

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013