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Endoscopic Vessel Harvesting During Coronary Bypass Surgery

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ClinicalTrials.gov Identifier: NCT00235846
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : April 14, 2015
Sponsor:
Information provided by (Responsible Party):
Jan Jesper Andreasen, MD, PhD, Aalborg Universitetshospital

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.

Condition or disease Intervention/treatment Phase
Coronary Arteriosclerosis Procedure: vein harvest Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic Vessel Harvesting During Coronary Bypass Surgery
Study Start Date : December 2004
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Conventional vein harvest
Conventional open vein harvest from the lower leg
Procedure: vein harvest
Conventional open vein harvest or endoscopic vein harvest
Experimental: Endoscopic vein harvest
Endoscopic vein harvest from the calf
Procedure: vein harvest
Conventional open vein harvest or endoscopic vein harvest



Primary Outcome Measures :
  1. Rate of wound complications [ Time Frame: 30 days ]
  2. Patient satisfaction [ Time Frame: 30 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective coronary artery bypass surgery

Exclusion Criteria:

  • Leg wounds
  • Acute surgery
  • Previous vascular surgery
  • Combined surgery (valve + coronary)
  • Arterial revascularization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00235846


Locations
Denmark
Aalborg Hospital
Aalborg, Denmark, DK-9100
Sponsors and Collaborators
Aalborg Universitetshospital
Investigators
Principal Investigator: Jan J Andreasen, MD Department of Cardiothoracic Surgery, Aalborg hospital, Hobrovej, postboks 365, DK-9100 Aalborg, Denmark

Publications:
Responsible Party: Jan Jesper Andreasen, MD, PhD, Professor, Aalborg Universitetshospital
ClinicalTrials.gov Identifier: NCT00235846     History of Changes
Other Study ID Numbers: VN 2004/14
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: April 2015

Keywords provided by Jan Jesper Andreasen, MD, PhD, Aalborg Universitetshospital:
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