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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05527756
Other study ID # f/2022/121
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 21, 2022
Est. completion date May 27, 2023

Study information

Verified date March 2024
Source Jessa Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date May 27, 2023
Est. primary completion date May 27, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Minimally Invasive Cardiac Surgery
  • Scar

Intervention

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

Locations

Country Name City State
Belgium Jessa Hospital Hasselt Limburg

Sponsors (1)

Lead Sponsor Collaborator
Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
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