Conventional Versus Mini-Sternotomy for Aortic Valve Surgery
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Valve Diseases |
Device: surgery techniques (sternotomy for aortic valve replacement) |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| 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
| Enrollment: | 78 |
| Study Start Date: | January 2002 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | January 2002 (Final data collection date for primary outcome measure) |
Background:
Minimally invasive techniques for cardiac surgery should be formally evaluated.
Design:
Randomized, single-blind, monocentric trial.
Interventions Compared:
Median sternotomy versus minimally invasive technique.
Eligibility Criteria:
Indication of isolated aortic valvular replacement, preoperative American Society of Anesthesiologists (ASA) class < = 3, left ventricular ejection fraction > = 40%.
Primary Outcome:
Forced expiratory volume and peak expiratory volume/second at 48 hours.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Indication of isolated aortic valvular replacement
- Preoperative ASA class < = 3
- Left ventricular ejection fraction > = 40%
- Signed informed consent
Exclusion Criteria:
- Aortic or mitral insufficiency > 3
- History of cardiac surgery
- Acute pulmonary edema
- Endocarditis
- Chronic renal insufficiency decompensation
- Operative coagulation disorders regardless of etiology
Contacts and Locations| France | |
| 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 |
More Information
No publications provided
| Responsible Party: | Jean Pierre LEROY, University Hospital, Bordeaux |
| ClinicalTrials.gov Identifier: | NCT00221663 History of Changes |
| Other Study ID Numbers: | 7945-00, 2000-05 |
| Study First Received: | September 13, 2005 |
| Last Updated: | August 14, 2008 |
| Health Authority: | France: Ministry of Health |
Keywords provided by University Hospital, Bordeaux:
|
Cardiac surgery Aortic valve replacement Minimally invasive surgery Perioperative course |
Additional relevant MeSH terms:
|
Heart Valve Diseases Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013