Validating patient-reported outcomes in breast reconstruction
Official title: Validation of Scales in Reconstructive Breast Surgery
Run by Vastra Gotaland Region · NCT05233891 · Data updated 2026-11-12
This study is testing if certain questionnaires can accurately capture how patients feel after breast reconstruction surgery to help improve their care and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | Women only |
| Enrollment | 500 (estimated) |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 1 site (Gothenburg) |
| Status | Recruiting |
| Started | June 21, 2021 |
| Main results expected | December 21, 2027 |
| Study ends | December 21, 2027 |
| Registry record updated | July 3, 2025 |
| Trial ID | NCT05233891 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women who have had or will have reconstructive breast surgery at Sahlgrenska University Hospital.
✕Probably not a fit
Patients who do not understand Swedish will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project aims to validate patient-reported outcome measures (PROMs) specifically for reconstructive breast surgery. It will assess the BREAST-Q tool along with the Hospital Anxiety and Depression Scale (HADS), EuroQol 5D (EQ5D), and SF-36 to ensure their effectiveness in this context. Additionally, the study will validate the Clavien-Dindo complication classification system for use in reconstructive breast surgery. The focus is on gathering reliable data to improve patient care and outcomes in breast reconstruction.
Why it matters
Potential benefit: If successful, this study could enhance the quality of care and outcomes for patients undergoing reconstructive breast surgery.
How similar studies have gone: Other studies have shown success in validating patient-reported outcomes in surgical contexts, making this approach promising.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women who have had or will have reconstructive breast surgery in Sahlgrenska university hospital. Exclusion Criteria: * Do not understand Swedish.
Where it's running
-
Sahlgrenska university hospital
Gothenburg, Sweden Recruiting
Study contacts
- Study coordinator: Emma Hansson, MD, PhD
- Email: emma.em.hansson@vgregion.se
- Phone: +46313421000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.