Clinical trial NCT05527756: Evaluation of the Cosmetic Outcomes of Totally Endoscopic Cardiac Surgery
Official title: Evaluation of the Cosmetic Outcomes of Totally Endoscopic Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Minimally Invasive Cardiac Surgery
Scar
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the cosmesis through the Scar Cosmesis Assessment and Rating (SCAR) scale at postoperative day one.
timeFrame: Postoperative day one
measure: Evaluate the cosmesis through the Scar Cosmesis Assessment and Rating (SCAR) scale at postoperative day 14.
timeFrame: Postoperative day 14
measure: Evaluate the cosmesis through the Scar Cosmesis Assessment and Rating (SCAR) scale at postoperative day 30.
timeFrame: Postoperative day 30
Secondary outcomes:
measure: Cosmetic assessment from the patients through the numerical rating scale (NRS) at postoperative day one.
timeFrame: Postoperative day one
measure: Cosmetic assessment from the patients through the numerical rating scale (NRS) at postoperative day 14.
timeFrame: Postoperative day 14
measure: Cosmetic assessment from the patients through the numerical rating scale (NRS) at postoperative day 30.
timeFrame: Postoperative day 30
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
state: Limburg
Study officials:
affiliation: Jessa Hospital
name: Alaaddin Yilmaz, MD
role: STUDY_CHAIR
References: