NCT05527756|Completed
Evaluation of the Cosmetic Outcomes of Totally Endoscopic Cardiac Surgery
SCARMICS
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SCARMICS
Sponsor study identifier
observational
80
1 country
1
Study Start
October 21, 2022
Actual (reported)Primary Completion
May 27, 2023
Actual (reported)Study Completion
May 27, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 27, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 31, 2022
Actual (reported)September 6, 2022
Actual (reported)October 21, 2022
Actual (reported)May 27, 2023
Actual (reported)May 27, 2023
Actual (reported)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
Cosmetic assessment from the patients through the numerical rating scale (NRS) at postoperative day one.
Postoperative day one
Cosmetic assessment from the patients through the numerical rating scale (NRS) at postoperative day 14.
Postoperative day 14
Cosmetic assessment from the patients through the numerical rating scale (NRS) at postoperative day 30.
Postoperative day 30
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.
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.
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
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.
Jessa Hospital
Hasselt, Limburg, Belgium
Alaaddin Yilmaz, MD
Jessa Hospital
80 participants (actual enrollment reported by the registry).
First Submitted
August 31, 2022
First Posted
September 6, 2022
Study Start
October 21, 2022
Actual (reported)The NRS scale, in which the patients score the cosmetic appearance of the scar from 0 to 10, is questioned.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
May 27, 2023
Actual (reported)Study Completion
May 27, 2023
Actual (reported)Last Updated
March 6, 2024
Record last verified: 2024-03
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Source: ClinicalTrials.gov.
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