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
  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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014