Endoscopic Vessel Harvesting During Coronary Bypass Surgery

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

Resource links provided by NLM:


Further study details as provided by Aalborg Universityhospital:

Primary Outcome Measures:
  • 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)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235846

Locations
Denmark
Aalborg Hospital
Aalborg, Denmark, DK-9100
Sponsors and Collaborators
Aalborg Universityhospital
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, 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
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases

ClinicalTrials.gov processed this record on October 16, 2014