Cardiac DiseaseNCT03902717
Patient-centered and Clinical Outcomes After Minimally Invasive Cardiothoracic Surgery
An observational study of Cardiac Disease and Surgery, run by Jessa Hospital at 2 sites in Belgium.
Trial summary
Nowadays, minimally invasive cardiothoracic surgery techniques are being performed to treat patients with coronary heart diseases. These newly developed procedures include laparoscopic techniques that do not require median sternotomy, which has several beneficial effects for both patient and the hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease, Surgery
- What is being tested?
- Minimally invasive cardiac surgery
- Type of treatment
- Surgery or procedure
- How many people
- 209 participants
- Where
- 2 sitesBelgium
- Study dates
- 25 Nov 2019to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients that are scheduled to undergo minimally invasive cardiac surgery, open CABG or TAVI
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Jessa Hospital
Hasselt, Limburg, 3500
Department of Anesthesiology and Intensive Care
Hasselt, 3500
About this study
Official title: An Observational Cohort Study to Investigate Patient-centered and Clinical Outcomes After Minimally Invasive Cardiothoracic Surgery
Nowadays, minimally invasive cardiothoracic surgery techniques are being performed to treat patients with coronary heart diseases. These newly developed procedures include laparoscopic techniques that do not require median sternotomy, which has several beneficial effects for both patient and the hospital. Although retrospective data 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 observational prospective 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).
Read the 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.
- Conditions
- Cardiac Disease, Surgery
- Being tested
- Minimally invasive cardiac surgery
- Keywords
- Minimally invasive cardiac surgery, Endoscopic coronary artery bypass grafting
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive cardiac surgeryProcedure or surgery
Patients will undergo minimally invasive cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| minimally invasive cardiac surgery | Group of patients that will undergo minimally invasive cardiac surgery Receives: Procedure: Minimally invasive cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery
Quality of Recovery will be assessed via 2 questionnaires: the SF-36 and EQ-5D questionnaire concerning mobility, selfcare, daily activities and pain
Measured: 1 month after surgery
Secondary outcomes (9)
Quality of Recovery
Quality of Recovery will be assessed via 2 questionnaires: the SF-36 and EQ-5D questionnaire concerning mobility, selfcare, daily activities and pain
Measured: 2 weeks after surgery
Quality of Recovery
Quality of Recovery will be assessed via 2 questionnaires: the SF-36 and EQ-5D questionnaire concerning mobility, selfcare, daily activities and pain
Measured: 3 months after surgery
Quality of Recovery
Quality of Recovery will be assessed via 2 questionnaires: the SF-36 and EQ-5D questionnaire concerning mobility, selfcare, daily activities and pain
Measured: 12 months after surgery
Routine measurements of standard medical practice
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)
Measured: 12 months after surgery
Patient satisfaction with respect to surgery
Patient satisfaction after surgery (assessed via the 7-point likert scale, with 1 being completely dissatisfied and 7 completely satisfied)
Measured: 3 months after surgery
Physical recovery of patients after surgery
A maximal exercise test will be performed after surgery to asses revalidation of the patients
Measured: 2 weeks after surgery
Physical recovery of patients after surgery
A maximal exercise test will be performed after surgery to asses revalidation of the patients
Measured: 1 month after surgery
Physical recovery of patients after surgery
A maximal exercise test will be performed after surgery to asses revalidation of the patients
Measured: 3 months after surgery
Physical recovery of patients after surgery
A maximal exercise test will be performed after surgery to asses revalidation of the patients
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start25 Nov 2019
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stessel Björn, Jessa Hospital
- Investigators
- Björn Stessel, MD, PhD, Principal investigator, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902717
- Sponsor's protocol ID
- 18.47/ANESTH18.04
- Status last verified
- Feb 2022
- First submitted
- 28 Mar 2019
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25924029Diodato 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.
PubMed 25374960Ruel 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.
PubMed 24183338Lapierre 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.
PubMed 21393011Poston 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.
PubMed 18936577McGinn 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.
PubMed 19752390Biglioli 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.
PubMed 10969662
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Cohort Study to Investigate Patient-centered and Clinical Outcomes After Minimally Invasive Cardiothoracic Surgery
- ClinicalTrials.gov ID
- NCT03902717
- Acronym / sponsor ID
- 18.47/ANESTH18.04
- Conditions
- Cardiac Disease, Surgery
- Keywords
- Minimally invasive cardiac surgery, Endoscopic coronary artery bypass grafting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 4 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nowadays, minimally invasive cardiothoracic surgery techniques are being performed to treat patients with coronary heart diseases. These newly developed procedures include laparoscopic techniques that do not require median sternotomy, which has several beneficial effects for both patient and the hospital. Although retrospective data 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 observational prospective 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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| minimally invasive cardiac surgery | – | Procedure: Minimally invasive cardiac surgeryGroup of patients that will undergo minimally invasive cardiac surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients that are scheduled to undergo minimally invasive cardiac surgery, open CABG or TAVI
Key inclusion criteria (7 listed)
- Males and females ≥ 18 years of age
- Patients planned to undergo minimally invasive cardiac surgery by the following techniques:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally invasive cardiac surgeryPatients will undergo minimally invasive cardiac surgery | Procedure or surgery | minimally invasive cardiac surgery |
Primary outcome
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
9 secondary outcomes
Quality of Recovery
Time frame: 2 weeks after surgery
Quality of Recovery
Time frame: 3 months after surgery
Quality of Recovery
Time frame: 12 months after surgery
Routine measurements of standard medical practice
Time frame: 12 months after surgery
Patient satisfaction with respect to surgery
Time frame: 3 months after surgery
Physical recovery of patients after surgery
Time frame: 2 weeks after surgery
Physical recovery of patients after surgery
Time frame: 1 month after surgery
Physical recovery of patients after surgery
Time frame: 3 months after surgery
Physical recovery of patients after surgery
Time frame: 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Background: PubMed 25924029Ezelsoy 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.
- Background: PubMed 25374960Diodato 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.
- Background: PubMed 24183338Ruel 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.
- Background: PubMed 21393011Lapierre 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.
- Background: PubMed 18936577Poston 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.
- Background: PubMed 19752390McGinn 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.
- Background: PubMed 10969662Biglioli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Björn Stessel, MD, PhD principal investigator
Jessa Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Disease and Surgery, run by Jessa Hospital at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery (time frame: 1 month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03902717, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.