Evaluation of the Cosmetic Outcomes of Totally Endoscopic Cardiac Surgery

NCT05527756 | Completed

• 1 other identifier: f/2022/121
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Minimally Invasive Cardiac Surgery; Scar

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• 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 Arms (2)

Totally endoscopic aortic/mitral valve replacement

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.

Other: Scar Cosmesis Assessment and Rating (SCAR) scale; Other: Numerical rating scale (NRS)

Totally endoscopic coronary artery bypass grafting

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.

Other: Scar Cosmesis Assessment and Rating (SCAR) scale; Other: Numerical rating scale (NRS)

Interventions

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

Totally endoscopic aortic/mitral valve replacement; Totally endoscopic coronary artery bypass grafting

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.

Totally endoscopic aortic/mitral valve replacement; Totally endoscopic coronary artery bypass grafting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients older than 18 years old
• Patients who can give their informed consent
• Patients who speak Dutch or French

You may not qualify if:

• Patients that previously underwent cardiac surgery
• Patients that will undergo a combination of cardiac surgeries

Sponsors & Collaborators

• Jessa Hospital: lead

Study Sites (1)

Jessa Hospital

Hasselt, Limburg, Belgium

Location

MeSH Terms

Conditions

Cicatrix

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Alaaddin Yilmaz, MD

  Jessa Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 6, 2022
• Study Start: October 21, 2022
• Primary Completion: May 27, 2023
• Study Completion: May 27, 2023
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)