- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03902717
Patient-centered and Clinical Outcomes After Minimally Invasive Cardiothoracic Surgery
An Observational Cohort Study to Investigate Patient-centered and Clinical Outcomes After Minimally Invasive Cardiothoracic Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Introduction:
Coronary artery disease is a leading cause of adult mortality worldwide. One of the most commonly performed surgical interventions to treat this vascular disease is a myocardial revascularization, mostly performed via a Coronary Artery Bypass Graft (CABG) (1). Over time, new developments in cardiac surgery have led to the introduction of less invasive and minimally invasive cardiac procedures (2). These minimally invasive cardiac procedures are proven to be safe and feasible (3) and have excellent outcomes (4) (5) (6). More specifically, the short term outcomes include a reduced patient recovery time (5), lower transfusion rates, wound infections, hospitalization time and hospital mortality rate (4), while the long term outcomes comprise a better vessel graft patency (7) (8). Over the past few years, new minimally invasive cardiothoracic surgery techniques have been developed and are currently being implemented at the department of cardiothoracic surgery from the Jessa Hospital (e.g. endo-CABG, VATS Mitral, hybrid revascularization, Yil AVR). These newly developed procedures include laparoscopic techniques that do not require median sternotomy, which has several beneficial effects for both patient and the hospital. Also, these techniques allow a coronary revascularization or mitral valve repair or replacement without the use of expensive robotic equipment and exclusion of specific patients based on comorbidities (e.g. elderly patients, diabetic and/or obese patients). Currently, patients undergo cardiothoracic surgery via these techniques and although retrospective data from our hospital show promising results with respect to clinical outcomes (e.g. 30-day mortality rate, intensive care unit length of stay), no prospective data with respect to patient centered outcomes (e.g. quality of recovery, quality of life) are available yet. Therefore, the aim of this study is to explore several patient centered and clinical outcomes of patients that are treated with these newly developed minimally invasive cardiac procedures.The comparative group consists of patients undergoing open CABG (invasive) and patients undergoing a Transcatheter Aortic Valve Implantation (TAVI).
Outcome measures:
The goal of this study is to assess several patient central outcomes (e.g. quality of recovery measured with quality of life) and clinical outcomes (e.g. mortality rate, serious complications, major cardiac events, time registration in icu and hospital, duration of surgery, occlusion and perfusion time, surgical parameters, revalidation of the patients) after minimally invasive cardiothoracic surgery.
Design:
This study is a single-center prospective observational cohort study in which eligible patients that are treated via minimally invasive cardiac surgery will be included. Inclusion will last for 1 year and patients will be followed-up for 12 months.
Study Procedures:
After signing the informed consent form, the baseline tests will be performed the day before the surgery. On the day of the surgery, several surgical parameters will be measured as well as several parameters that are included in the standard clinical practice. 2 weeks, 1 month, 3 months and 1 year after the surgery, the QoL will be measured. Patient satisfaction will be assessed 3 months after surgery.
Statistical analysis:
Descriptive statistics will be presented as frequencies and percentages of the total amount of patients for categorical variables, while numerical variables will be presented as mean with variances. Results of the different questionnaires will be calculated according to their specific guidelines. The clinical significance of the questionnaires will be calculated via an effect size. A p-value <0.05 is considered statistical significant, while p<0.10 is considered a tendency.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Hasselt, Belgium, 3500
- Department of Anesthesiology and Intensive Care
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Limburg
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Hasselt, Limburg, Belgium, 3500
- Jessa Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Males and females ≥ 18 years of age
Patients planned to undergo minimally invasive cardiac surgery by the following techniques:
- Endo-CABG
- Hybrid approach
- VATS Mitral
- Mini AVR
- Yil AVR or open CABG or TAVI
Exclusion Criteria:
- Patients < 18 years old
- Patients that are not eligible to undergo minimally invasive cardiac surgery
- Patients that participate in other clinical, pharmaceutical or medical devices trials
- Patients that previously had a minimally invasive cardiac surgery and are now scheduled for a revision
- Patients that need a conversion to sternotomy or other non-minimally invasive technique
- Inability to understand and adhere to the study design
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
minimally invasive cardiac surgery
Group of patients that will undergo minimally invasive cardiac surgery
|
Patients will undergo minimally invasive cardiac surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Recovery
Time Frame: 1 month after surgery
|
Quality of Recovery will be assessed via 2 questionnaires: the SF-36 and EQ-5D questionnaire concerning mobility, selfcare, daily activities and pain
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1 month after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Recovery
Time Frame: 2 weeks after surgery
|
Quality of Recovery will be assessed via 2 questionnaires: the SF-36 and EQ-5D questionnaire concerning mobility, selfcare, daily activities and pain
|
2 weeks after surgery
|
Quality of Recovery
Time Frame: 3 months after surgery
|
Quality of Recovery will be assessed via 2 questionnaires: the SF-36 and EQ-5D questionnaire concerning mobility, selfcare, daily activities and pain
|
3 months after surgery
|
Quality of Recovery
Time Frame: 12 months after surgery
|
Quality of Recovery will be assessed via 2 questionnaires: the SF-36 and EQ-5D questionnaire concerning mobility, selfcare, daily activities and pain
|
12 months after surgery
|
Routine measurements of standard medical practice
Time Frame: 12 months after surgery
|
Routine measurements during and after surgery (e.g.
amount of blood loss, time of ventilation, time of perfusion, hematology/blood chemistry, registration of mortality rates and complications after surgery, length of stay at the ICU department after surgery, length of stay in the hospital)
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12 months after surgery
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Patient satisfaction with respect to surgery
Time Frame: 3 months after surgery
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Patient satisfaction after surgery (assessed via the 7-point likert scale, with 1 being completely dissatisfied and 7 completely satisfied)
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3 months after surgery
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Physical recovery of patients after surgery
Time Frame: 2 weeks after surgery
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A maximal exercise test will be performed after surgery to asses revalidation of the patients
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2 weeks after surgery
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Physical recovery of patients after surgery
Time Frame: 1 month after surgery
|
A maximal exercise test will be performed after surgery to asses revalidation of the patients
|
1 month after surgery
|
Physical recovery of patients after surgery
Time Frame: 3 months after surgery
|
A maximal exercise test will be performed after surgery to asses revalidation of the patients
|
3 months after surgery
|
Physical recovery of patients after surgery
Time Frame: 12 months after surgery
|
A maximal exercise test will be performed after surgery to asses revalidation of the patients
|
12 months after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Björn Stessel, MD, PhD, Jessa hospital, Hasselt
Publications and helpful links
General Publications
- Ezelsoy M, Caynak B, Bayram M, Oral K, Bayramoglu Z, Sagbas E, Aytekin V, Akpinar B. The Comparison between Minimally Invasive Coronary Bypass Grafting Surgery and Conventional Bypass Grafting Surgery in Proximal LAD Lesion. Heart Surg Forum. 2015 Apr 28;18(2):E042-6. doi: 10.1532/hsf.1239.
- Diodato M, Chedrawy EG. Coronary artery bypass graft surgery: the past, present, and future of myocardial revascularisation. Surg Res Pract. 2014;2014:726158. doi: 10.1155/2014/726158. Epub 2014 Jan 2.
- Ruel M, Shariff MA, Lapierre H, Goyal N, Dennie C, Sadel SM, Sohmer B, McGinn JT Jr. Results of the Minimally Invasive Coronary Artery Bypass Grafting Angiographic Patency Study. J Thorac Cardiovasc Surg. 2014 Jan;147(1):203-8. doi: 10.1016/j.jtcvs.2013.09.016. Epub 2013 Oct 30.
- Lapierre H, Chan V, Sohmer B, Mesana TG, Ruel M. Minimally invasive coronary artery bypass grafting via a small thoracotomy versus off-pump: a case-matched study. Eur J Cardiothorac Surg. 2011 Oct;40(4):804-10. doi: 10.1016/j.ejcts.2011.01.066. Epub 2011 Mar 9.
- Poston RS, Tran R, Collins M, Reynolds M, Connerney I, Reicher B, Zimrin D, Griffith BP, Bartlett ST. Comparison of economic and patient outcomes with minimally invasive versus traditional off-pump coronary artery bypass grafting techniques. Ann Surg. 2008 Oct;248(4):638-46. doi: 10.1097/SLA.0b013e31818a15b5.
- McGinn JT Jr, Usman S, Lapierre H, Pothula VR, Mesana TG, Ruel M. Minimally invasive coronary artery bypass grafting: dual-center experience in 450 consecutive patients. Circulation. 2009 Sep 15;120(11 Suppl):S78-84. doi: 10.1161/CIRCULATIONAHA.108.840041.
- Biglioli P, Antona C, Alamanni F, Parolari A, Toscano T, Pompilio G, Polvani G. Minimally invasive direct coronary artery bypass grafting: midterm results and quality of life. Ann Thorac Surg. 2000 Aug;70(2):456-60. doi: 10.1016/s0003-4975(00)01371-0.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18.47/ANESTH18.04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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