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

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: Completed
• Conditions: Scar; Minimally Invasive Cardiac Surgery
• Intervention / Treatment: Other: Scar Cosmesis Assessment and Rating (SCAR) scale; Other: Numerical rating scale (NRS)

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: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Evaluate the cosmesis through the Scar Cosmesis Assessment and Rating (SCAR) scale at 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.	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.	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

Outcome Measure	Measure Description	Time Frame
Cosmetic assessment from the patients through the numerical rating scale (NRS) at 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.	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.	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

• Sponsor: Jessa Hospital
• Investigators: Study Chair: Alaaddin Yilmaz, MD, Jessa Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2022
• Primary Completion (Actual): May 27, 2023
• Study Completion (Actual): May 27, 2023

Study Registration Dates

• First Submitted: August 31, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 6, 2022

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID 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