Endoscopic Vessel Harvesting During Coronary Bypass Surgery

This study has been completed.
Sponsor:
Information provided by:
Aalborg Universitetshospital
ClinicalTrials.gov Identifier:
NCT00235846
First received: October 10, 2005
Last updated: August 5, 2008
Last verified: December 2007

October 10, 2005
August 5, 2008
December 2004
July 2007   (final data collection date for primary outcome measure)
  • Rate of wound complications [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Patient satisfaction [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Rate of wound complications
  • Patient satisfaction
Complete list of historical versions of study NCT00235846 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Arteriosclerosis
Procedure: Endoscopic saphenous vein harvesting
Not Provided
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. 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00235846
VN 2004/14
No
Jan Jesper Andreasen, MD, Aalborg Hospital, Aarhus University Hospital
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
December 2007

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