Endoscopic Vessel Harvesting During Coronary Bypass Surgery
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Coronary Arteriosclerosis |
Procedure: Endoscopic saphenous vein harvesting |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Endoscopic Vessel Harvesting During Coronary Bypass Surgery |
- Rate of wound complications [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Patient satisfaction [ Time Frame: 30 days ] [ Designated as safety issue: No ]
| Enrollment: | 132 |
| Study Start Date: | December 2004 |
| Study Completion Date: | July 2007 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Elective coronary artery bypass surgery
Exclusion Criteria:
- Leg wounds
- Acute surgery
- Previous vascular surgery
- Combined surgery (valve + coronary)
- Arterial revascularization
Contacts and Locations| Denmark | |
| Aalborg Hospital | |
| Aalborg, Denmark, DK-9100 | |
| Principal Investigator: | Jan J Andreasen, MD | Department of Cardiothoracic Surgery, Aalborg hospital, Hobrovej, postboks 365, DK-9100 Aalborg, Denmark |
More Information
Publications:
| Responsible Party: | Jan Jesper Andreasen, MD, Aalborg Hospital, Aarhus University Hospital |
| ClinicalTrials.gov Identifier: | NCT00235846 History of Changes |
| Other Study ID Numbers: | VN 2004/14 |
| Study First Received: | October 10, 2005 |
| Last Updated: | August 5, 2008 |
| Health Authority: | Denmark: The Regional Committee on Biomedical Research Ethics |
Keywords provided by Aalborg Universityhospital:
|
Endoscopic vein harvesting Saphenous vein |
Additional relevant MeSH terms:
|
Arteriosclerosis Coronary Artery Disease Myocardial Ischemia Arterial Occlusive Diseases |
Vascular Diseases Cardiovascular Diseases Coronary Disease Heart Diseases |
ClinicalTrials.gov processed this record on June 17, 2013