Evaluation of the Cosmetic Outcomes of Totally Endoscopic Cardiac Surgery

NCT ID: NCT05527756

Last Updated: 2024-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-21

Study Completion Date

2023-05-27

Brief Summary

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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

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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.

Conditions

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Minimally Invasive Cardiac Surgery Scar

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Scar Cosmesis Assessment and Rating (SCAR) scale

Intervention Type 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)

Intervention Type OTHER

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

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.

Scar Cosmesis Assessment and Rating (SCAR) scale

Intervention Type 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)

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Numerical rating scale (NRS)

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jessa Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alaaddin Yilmaz, MD

Role: STUDY_CHAIR

Jessa Hospital

Locations

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Jessa Hospital

Hasselt, Limburg, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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f/2022/121

Identifier Type: -

Identifier Source: org_study_id

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