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Clinical Trials/NCT05527756
NCT05527756CompletedNot Applicable

Evaluation of the Cosmetic Outcomes of Totally Endoscopic Cardiac Surgery

Jessa Hospital1 site in 1 country80 target enrollmentStarted: October 21, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
80
Locations
1
Primary Endpoint
Evaluate the cosmesis through the Scar Cosmesis Assessment and Rating (SCAR) scale at postoperative day 30.

Study Overview

Brief 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.

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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.

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.

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.

Secondary Outcomes

  • 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)

Investigators

Sponsor
Jessa Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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