Evaluation of the Cosmetic Outcomes of Totally Endoscopic Cardiac Surgery (SCARMICS)

March 5, 2024 updated by: Jessa Hospital
Totally endoscopic cardiac surgery (TECS) is considered to have aesthetic advantages over conventional median sternotomy due to the smaller incisions. Most research regarding TECS focuses on clinical outcomes instead of cosmetic consequences. Following surgery, postoperative scarring is unavoidable and may negatively affect the patient's physical and emotional well-being. Therefore, this study aims to investigate the cosmesis after TECS.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Totally endoscopic cardiac surgery (TECS) is considered to have aesthetic advantages over conventional median sternotomy due to the smaller incisions. Most research regarding TECS focuses on clinical outcomes instead of cosmetic consequences. Following surgery, postoperative scarring is unavoidable and may negatively affect the patient's physical and emotional well-being. One previous study compared median sternotomy cardiac surgery and TECS in terms of the long-term cosmetic appearance of postoperative scars. They concluded that scars were considered more satisfactory, less painful, and itchy in the TECS group in the Chinese population. To our knowledge, this is the only study published regarding cosmetic consequences after TECS. Therefore, this study aims to investigate the cosmesis after TECS.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
    • Limburg
      • Hasselt, Limburg, Belgium
        • Jessa Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All patients that undergo totally endoscopic aortic valve replacement (TEAVR), totally endoscopic mitral valve (MVATS) and totally endoscopic coronary artery bypass grafting (Endo-CABG) at the Department of Cardiothoracic Surgery of the Jessa Hospital, Hasselt will be screened for eligibility.

Description

Inclusion Criteria:

  • Patients older than 18 years old
  • Patients who can give their informed consent
  • Patients who speak Dutch or French

Exclusion Criteria:

  • Patients that previously underwent cardiac surgery
  • Patients that will undergo a combination of cardiac surgeries

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Totally endoscopic aortic/mitral valve replacement
Study procedures include the Scar Cosmesis Assessment and Rating (SCAR) scale and numerical rating scale (NRS) questionnaire at one, 14 and 30 days after totally endoscopic aortic/mitral valve replacement. Additionally, a photo of the incisions will be taken at these time points.
Other: Scar Cosmesis Assessment and Rating (SCAR) scale
The SCAR scale consists of two simple questions about symptoms (itch and pain) with yes/no response options that are responded to by the patient and six clinician-related items that are rated by observers through photos of the incisions. This scale includes both objective measurements and patient-reported symptoms
Other: Numerical rating scale (NRS)
The NRS scale, in which the patients score the cosmetic appearance of the scar from 0 to 10, is questioned.
Totally endoscopic coronary artery bypass grafting
Study procedures include the Scar Cosmesis Assessment and Rating (SCAR) scale and numerical rating scale (NRS) questionnaire at one, 14 and 30 days after totally endoscopic coronary artery bypass grafting. Additionally, a photo of the incisions will be taken at these time points.
Other: Scar Cosmesis Assessment and Rating (SCAR) scale
The SCAR scale consists of two simple questions about symptoms (itch and pain) with yes/no response options that are responded to by the patient and six clinician-related items that are rated by observers through photos of the incisions. This scale includes both objective measurements and patient-reported symptoms
Other: Numerical rating scale (NRS)
The NRS scale, in which the patients score the cosmetic appearance of the scar from 0 to 10, is questioned.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluate the cosmesis through the Scar Cosmesis Assessment and Rating (SCAR) scale at postoperative day one.
Time Frame: Postoperative day one
The SCAR scale includes both objective measurements and patient-reported symptoms. A low score corresponds to a good scar cosmesis and a high score to a bad scar cosmesis.
Postoperative day one
Evaluate the cosmesis through the Scar Cosmesis Assessment and Rating (SCAR) scale at postoperative day 14.
Time Frame: Postoperative day 14
The SCAR scale includes both objective measurements and patient-reported symptoms. A low score corresponds to a good scar cosmesis and a high score to a bad scar cosmesis.
Postoperative day 14
Evaluate the cosmesis through the Scar Cosmesis Assessment and Rating (SCAR) scale at postoperative day 30.
Time Frame: Postoperative day 30
The SCAR scale includes both objective measurements and patient-reported symptoms. A low score corresponds to a good scar cosmesis and a high score to a bad scar cosmesis.
Postoperative day 30

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cosmetic assessment from the patients through the numerical rating scale (NRS) at postoperative day one.
Time Frame: Postoperative day one
The cosmetic appearance of the scar is scored from 0 to 10, whereas 0 contributes to not satisfied with the scar and 10 with very satisfied with the scar.
Postoperative day one
Cosmetic assessment from the patients through the numerical rating scale (NRS) at postoperative day 14.
Time Frame: Postoperative day 14
The cosmetic appearance of the scar is scored from 0 to 10, whereas 0 contributes to not satisfied with the scar and 10 with very satisfied with the scar.
Postoperative day 14
Cosmetic assessment from the patients through the numerical rating scale (NRS) at postoperative day 30.
Time Frame: Postoperative day 30
The cosmetic appearance of the scar is scored from 0 to 10, whereas 0 contributes to not satisfied with the scar and 10 with very satisfied with the scar.
Postoperative day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jessa Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Alaaddin Yilmaz, MD, Jessa Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 21, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 27, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 27, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • f/2022/121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings