Back to resultsUse of Seamguard to Prevent Leak and Bleeding in Gastrointestinal Surgery
Primary Purpose
Leak on Lineal Stapled Anastomoses, Bleeding on Lineal Stapled Anastomoses
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Seamguard
Sponsored by
About this trial
This is an interventional prevention trial for Leak on Lineal Stapled Anastomoses focused on measuring Seamguard, staple-line reinforcement, leak, bleeding
Eligibility Criteria
Inclusion Criteria:
- All patients who will need a lineal stapled anastomoses (colon cancer in cecum, for example)
Exclusion Criteria:
- circular anastomoses
- bariatric surgery
Sites / Locations
- Hospital Universitario de Canarias
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
1
2
Arm Description
without seamguard
with seamguard
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01180140
First Posted
July 18, 2010
Last Updated
August 10, 2010
Sponsor
Hospital Universitario de Canarias
Collaborators
Unidad mixta de Investigación HUC-ULL, University of La Laguna
1. Study Identification
Unique Protocol Identification Number
NCT01180140
Brief Title
Use of Seamguard to Prevent Leak and Bleeding in Gastrointestinal Surgery
Official Title
Use of Seamguard to Prevent Digestive Leak and Bleeding on Lineal Stapled Anastomoses: a Prospective Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Universitario de Canarias
Collaborators
Unidad mixta de Investigación HUC-ULL, University of La Laguna
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leak on Lineal Stapled Anastomoses, Bleeding on Lineal Stapled Anastomoses
Keywords
Seamguard, staple-line reinforcement, leak, bleeding
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
without seamguard
Arm Title
2
Arm Type
Experimental
Arm Description
with seamguard
Intervention Type
Device
Intervention Name(s)
Seamguard
Intervention Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients who will need a lineal stapled anastomoses (colon cancer in cecum, for example)
Exclusion Criteria:
circular anastomoses
bariatric surgery
Facility Information:
Facility Name
Hospital Universitario de Canarias
City
La Laguna
State/Province
Santa Cruz de Tenerife
ZIP/Postal Code
38320
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Use of Seamguard to Prevent Leak and Bleeding in Gastrointestinal Surgery
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