Endoscopic Vessel Harvesting During Coronary Bypass Surgery

NCT ID: NCT00235846

Last Updated: 2015-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2007-07-31

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.

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.

Conditions

Coronary Arteriosclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional vein harvest

Conventional open vein harvest from the lower leg

Group Type: ACTIVE_COMPARATOR

vein harvest

Intervention Type: PROCEDURE

Conventional open vein harvest or endoscopic vein harvest

Endoscopic vein harvest

Endoscopic vein harvest from the calf

Group Type: EXPERIMENTAL

vein harvest

Intervention Type: PROCEDURE

Conventional open vein harvest or endoscopic vein harvest

Interventions

vein harvest

Conventional open vein harvest or endoscopic vein harvest

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Elective coronary artery bypass surgery

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aalborg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jan Jesper Andreasen, MD, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jan J Andreasen, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiothoracic Surgery, Aalborg hospital, Hobrovej, postboks 365, DK-9100 Aalborg, Denmark

Locations

Aalborg Hospital

Aalborg, , Denmark

Countries

Denmark

References

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.

Reference Type: BACKGROUND

PMID: 18508277 (View on PubMed)

Other Identifiers

VN 2004/14

Identifier Type: -

Identifier Source: org_study_id