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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
October 10, 2005
October 12, 2005
April 14, 2015
December 2004
July 2007   (Final data collection date for primary outcome measure)
  • Rate of wound complications [ Time Frame: 30 days ]
  • Patient satisfaction [ Time Frame: 30 days ]
  • Rate of wound complications
  • Patient satisfaction
Complete list of historical versions of study NCT00235846 on ClinicalTrials.gov Archive Site
Not Provided
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Endoscopic Vessel Harvesting During Coronary Bypass Surgery
Endoscopic Vessel Harvesting During Coronary Bypass Surgery
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Coronary Arteriosclerosis
Procedure: vein harvest
Conventional open vein harvest or endoscopic vein harvest
  • Active Comparator: Conventional vein harvest
    Conventional open vein harvest from the lower leg
    Intervention: Procedure: vein harvest
  • Experimental: Endoscopic vein harvest
    Endoscopic vein harvest from the calf
    Intervention: Procedure: vein harvest
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
132
July 2007
July 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Elective coronary artery bypass surgery

Exclusion Criteria:

  • Leg wounds
  • Acute surgery
  • Previous vascular surgery
  • Combined surgery (valve + coronary)
  • Arterial revascularization
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT00235846
VN 2004/14
No
Not Provided
Not Provided
Jan Jesper Andreasen, MD, PhD, Aalborg Universitetshospital
Aalborg Universitetshospital
Not Provided
Principal Investigator: Jan J Andreasen, MD Department of Cardiothoracic Surgery, Aalborg hospital, Hobrovej, postboks 365, DK-9100 Aalborg, Denmark
Aalborg Universitetshospital
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP