Validation of Scales in Reconstructive Breast Surgery (ValPlast)

Vastra Gotaland Region

Status: Enrolling

Conditions: Breast Cancer; Breast Hypertrophy

Treatments: Procedure: Breast reconstruction; Procedure: Breast reduction

Study type: Observational

Funder types: Other

Identifiers

NCT05233891

2021-03165

Details and patient eligibility

About

The main purpose of the project is to validate patient reported outcomes measures (PROMs) in reconstructive breast surgery. BREAST-Q will be evaluated for Swedish and Sweden.Hospital Anxiety and Depression Scale (HADS), EuroQol 5D (EQ5D), and SF-36 will be validated for reconstructive breast surgery. In addition, the complication classification system according to Clavien-Dindo will be validated for reconstructive breast surgery.

Enrollment: 500 estimated patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women who have had or will have reconstructive breast surgery in Sahlgrenska university hospital.

Exclusion criteria

• Do not understand Swedish.

Trial design

500 participants in 2 patient groups

Breast reconstruction after breast cancer

Description:

Women who have had/have breast cancer and will have/have had a breast reconstruction.

Treatment:

Procedure: Breast reconstruction

Breast reduction

Description:

Women who have had/will have a breast reduction due to breast hypertrophy.

Treatment:

Procedure: Breast reduction