Long-term Results Following Endoscopic Vein Harvesting in Coronary Artery Bypass Surgery
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Vena saphena magna is still frequently used as graft material in coronary artery bypass grating(CABG, and vein grafts can harvest with either the conventional open technique (Ovh = open vein harvesting), or with less invasive endoscopic techniques (EVH = Endoscopic vein harvesting). The endoscopic techniques have been shown to reduce the incidence of postoperative wound complications while patients are more satisfied with the cosmetic result of the operation on the leg.
Non-randomized studies have raised doubts about patency rates of the vein grafts following EVH compared to OVH, while other studies failed to detect any problems in relation to this. There are only very few data on long-term patency rates from randomized studies.
The purpose of this study is to investigate clinical outcome and patency rates of the vein grafts following either EVH and OVH in 132 patients who underwent CABG for 4-7 years ago as part of a randomized study investigation wound complications. A cost-effectiveness analysis will also be performed.
The hypothesis is: Patency rates following EVH are worse compared to OVH in CABG 4-7 years postoperatively.
| Condition |
|---|
|
Angina Pectoris |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Endoscopic Versus Open Vein Harvest in Coronary Artery Bypass Grafting. Clinical and CT-angiographic Long-term Result From a Randomized Study. |
- Patency rates of vein grafts [ Time Frame: 5-7 years postoperatively ] [ Designated as safety issue: No ]
- recurrence of angina pectoris [ Time Frame: 5-7 years postoperatively ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 132 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Endoscopic vein harvest |
| Open vein harvest |
Show Detailed Description Eligibility| Ages Eligible for Study: | 43 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
A total of 132 patients who underwent CABG 4-7 years ago. All patients participated in a randomized study focusing on wound complications from the leg following either open or endoscopic vein harvest.
Inclusion Criteria:
- Patients who participated in the previous randomized study
- Informed consent from the patient
Exclusion Criteria:
- Survival until date of reexamination
- No informed consent
- CT scan of the heart will not be performed in patients with if: atrial fibrillation,p-creatinin >120 micromol/l, allergy to contrast, pregnancy, lactating.
Contacts and Locations| Contact: Jan J. Andreasen, MD, PhD | +45 99322964 | jja@rn.dk |
| Denmark | |
| Aalborg Hospital | Not yet recruiting |
| Aalborg, Denmark, 9100 | |
| Contact: Jan J. Andreasen, MD, PhD | |
| Principal Investigator: Jan J. Andreasen, MD, PhD | |
| Principal Investigator: | Jan J. Andreasen, MD. PhD | Aalborg Universityhospital |
More Information
No publications provided
| Responsible Party: | Jan Jesper Andreasen, MD, PhD, Head of Department, MD, PhD, Aalborg Hospital |
| ClinicalTrials.gov Identifier: | NCT01480726 History of Changes |
| Other Study ID Numbers: | N20110023 |
| Study First Received: | November 24, 2011 |
| Last Updated: | November 28, 2011 |
| Health Authority: | Denmark: National Board of Health |
Additional relevant MeSH terms:
|
Angina Pectoris Myocardial Ischemia Heart Diseases Cardiovascular Diseases |
Vascular Diseases Chest Pain Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013