Clinical trial Recruiting at 1 site Observational Ages 18 to 100 Women only

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 typeObservational
Ages18 Years to 100 Years
SexWomen only
Enrollment500 (estimated)
SponsorVastra Gotaland Region
Government
Locations1 site (Gothenburg)
StatusRecruiting
StartedJune 21, 2021
Main results expectedDecember 21, 2027
Study endsDecember 21, 2027
Registry record updatedJuly 3, 2025
Trial IDNCT05233891 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.