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Completed

NCT Number: NCT05527756

Evaluation of the Cosmetic Outcomes of Totally Endoscopic Cardiac Surgery

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.

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Key information

Conditions

Minimally Invasive Cardiac Surgery Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Scar

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jessa Hospital

Hasselt, Limburg, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scar Cosmesis Assessment and Rating (SCAR) scale

Other

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

Numerical rating scale (NRS)

Other

The NRS scale, in which the patients score the cosmetic appearance of the scar from 0 to 10, is questioned.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Jessa Hospital

Other

Registry information

Acronym: SCARMICS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 6, 2022
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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