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Endoscopic Vessel Harvesting During Coronary Bypass Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00235846
First Posted: October 12, 2005
Last Update Posted: April 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jan Jesper Andreasen, MD, PhD, Aalborg Universitetshospital
  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: vein harvest

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic Vessel Harvesting During Coronary Bypass Surgery

Resource links provided by NLM:


Further study details as provided by Jan Jesper Andreasen, MD, PhD, Aalborg Universitetshospital:

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

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)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: October 10, 2005
First Posted: October 12, 2005
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