Conventional Versus Mini-Sternotomy for Aortic Valve Surgery
Minimally-invasive operative techniques have been introduced in cardiac surgery. These techniques may have several advantages such as a decrease in post operative pain, lower morbidity and mortality, faster recovery, and a shorter hospital stay. However, these advantages have rarely been documented in the setting of a formal randomized controlled trial.
Heart Valve Diseases
Device: surgery techniques (sternotomy for aortic valve replacement)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
|Official Title:||Clinical Trial Comparing a Conventional Median Sternotomy Versus a Minimally Invasive Technique for Aortic Valvular Replacement in Adults|
- Forced expiratory volume and peak expiratory volume/second [ Time Frame: at 48 hours ] [ Designated as safety issue: No ]
- Forced expiratory volume [ Time Frame: at 24 hours ]
- Peak expiratory volume/s at 24 hours
- Pro-inflammatory cytokines on tracheal aspiration samples
- Transfusion requirements during the first 24 hours post operative
- Hemodynamic parameters
- Duration of surgery extracorporeal circulation (ECC) and aortic-cross-clamp-time
- Consumption of analgetics
- Morbidity and mortality during hospital stay
|Study Start Date:||January 2002|
|Study Completion Date:||December 2006|
|Primary Completion Date:||January 2002 (Final data collection date for primary outcome measure)|
Minimally invasive techniques for cardiac surgery should be formally evaluated.
Randomized, single-blind, monocentric trial.
Median sternotomy versus minimally invasive technique.
Indication of isolated aortic valvular replacement, preoperative American Society of Anesthesiologists (ASA) class < = 3, left ventricular ejection fraction > = 40%.
Forced expiratory volume and peak expiratory volume/second at 48 hours.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00221663
|Hôpital Cardiologique du Haut Lévêque|
|Pessac, France, 33604|
|Principal Investigator:||Gerard Janvier, Pr||University Hospital, Bordeaux|
|Principal Investigator:||Joachim Calderon, Dr||University Hospital, Bordeaux France|
|Study Chair:||Geneviéve Chene, Pr||University Hospital, Bordeaux France|