Validation of Scales in Reconstructive Breast Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-100
SponsorVastra Gotaland Region
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women who have had or will have reconstructive breast surgery in Sahlgrenska university hospital.
Disqualifiers
Do not understand Swedish.
Trial population
Women who will have or have had reconstructive breast surgery.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Breast reconstruction
Procedure/SurgeryBreast reconstruction after breast cancer.
Breast reduction
Procedure/SurgeryBreast reduction due to breast hypertrophy.
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Breast reconstruction after breast cancer1 intervention
Group B: Breast reduction1 intervention
Trial outcomes
Primary outcomes
1
Validation and reliability of BREAST-Q for Sweden
Breast-Q measures breast related quality of life on a scale 1-100. A higher score indicates a higher quality of life.
Time frame
Pre-operatively2
Validation and reliability of BREAST-Q for Sweden
Breast-Q measures breast related quality of life on a scale 1-100. A higher score indicates a higher quality of life.
Time frame
5 years postoperatively3
Validation and reliability of EuroQol-5 dimensions, 3 levels for reconstructive breast surgery
EuroQol-5 dimensions-3 levels (EQ5D) is a generic instrument developed for health economic and clinical evaluation of healthcare. A total score between 0 and 1 is calculated. Zero equals death and 1 perfect health.
Time frame
Pre-operatively4
Validation and reliability of EuroQol-5 dimensions, 3 levels for reconstructive breast surgery
EuroQol-5 dimensions-3 levels (EQ5D) is a generic instrument developed for health economic and clinical evaluation of healthcare. A total score between 0 and 1 is calculated. Zero equals death and 1 perfect health.
Time frame
5 years postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov