Back to resultsEndoscopic Vessel Harvesting During Coronary Bypass Surgery
Primary Purpose
Coronary Arteriosclerosis
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
vein harvest
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Arteriosclerosis focused on measuring Endoscopic vein harvesting, Saphenous vein
Eligibility Criteria
Inclusion Criteria: Elective coronary artery bypass surgery Exclusion Criteria: Leg wounds Acute surgery Previous vascular surgery Combined surgery (valve + coronary) Arterial revascularization
Sites / Locations
- Aalborg Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional vein harvest
Endoscopic vein harvest
Arm Description
Conventional open vein harvest from the lower leg
Endoscopic vein harvest from the calf
Outcomes
Primary Outcome Measures
Rate of wound complications
Patient satisfaction
Secondary Outcome Measures
Full Information
NCT ID
NCT00235846
First Posted
October 10, 2005
Last Updated
April 13, 2015
Sponsor
Aalborg University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00235846
Brief Title
Endoscopic Vessel Harvesting During Coronary Bypass Surgery
Official Title
Endoscopic Vessel Harvesting During Coronary Bypass Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Conventional open vein harvesting from the legs during coronary artery bypass surgery result in wound complications among 30% of the patients. Endoscopic harvesting decrease the complication rate, but it remains to be shown whether this is also a fact among patient in whom only short segments of veingraft material is needed from the leg. We hypothesise that the rate of wound complications will be reduced and the patient satisfaction will be increased also among patients in whom only short vein segments are endoscopically harvested compared to conventional open vein harvesting.
Detailed Description
Conventional open vein harvesting from the legs during coronary artery bypass surgery result in wound complications among 30% of the patients. Endoscopic harvesting decrease the complication rate, but it remains to be shown whether this is also a fact among patient in whom only short segments of veingraft material is needed from the leg. We hypothesise that the rate of wound complications will be reduced and the patient satisfaction will be increased also among patients in whom only short vein segments are endoscopically harvested compared to conventional open vein harvesting.
Preoperative demographic as well ass peri- and postoperative data are collected prospectively at 5-7 days and 1 month postoperatively. Wound complications are registered as well as post operative pain in the wound is evaluated using af visual analogue scale. Patients are evaluating the cosmetic results after wound healing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Arteriosclerosis
Keywords
Endoscopic vein harvesting, Saphenous vein
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional vein harvest
Arm Type
Active Comparator
Arm Description
Conventional open vein harvest from the lower leg
Arm Title
Endoscopic vein harvest
Arm Type
Experimental
Arm Description
Endoscopic vein harvest from the calf
Intervention Type
Procedure
Intervention Name(s)
vein harvest
Intervention Description
Conventional open vein harvest or endoscopic vein harvest
Primary Outcome Measure Information:
Title
Rate of wound complications
Time Frame
30 days
Title
Patient satisfaction
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Elective coronary artery bypass surgery
Exclusion Criteria:
Leg wounds
Acute surgery
Previous vascular surgery
Combined surgery (valve + coronary)
Arterial revascularization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan J Andreasen, MD
Organizational Affiliation
Department of Cardiothoracic Surgery, Aalborg hospital, Hobrovej, postboks 365, DK-9100 Aalborg, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg Hospital
City
Aalborg
ZIP/Postal Code
DK-9100
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
18508277
Citation
Andreasen JJ, Nekrasas V, Dethlefsen C. Endoscopic vs open saphenous vein harvest for coronary artery bypass grafting: a prospective randomized trial. Eur J Cardiothorac Surg. 2008 Aug;34(2):384-9. doi: 10.1016/j.ejcts.2008.04.028. Epub 2008 May 27.
Results Reference
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Endoscopic Vessel Harvesting During Coronary Bypass Surgery
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