Informed Consent Regulation
For Participation in "Observational Research Lipedema: Diagnostic Delay, Psychological Impact, and Therapeutic Expectations — A Cross-Sectional Observational Study"

La Dott.ssa Luisella Troyer, che opererà in qualità di titolare del trattamento, nel pieno rispetto della legge europea 2016/679, fornisce le seguenti informazioni riguardanti il trattamento dei dati personali del paziente (di seguito 'interessato') ai fini dell'attribuzione dell'identità, per assolvere gli obblighi di legge di natura fiscale (dati anagrafici), di comunicazione tra paziente e studio (numeri telefonici, e-mail).

1. Study Information

Principal Investigator Dr. Luisella Troyer, Specialist in Vascular Surgery

Institution Salus Mea Outpatient Clinic, Milan, Italy

Contact segreteria@milanolinfedema.it

Study Period September 2023 – ongoing

2. Purpose of the Study

You are being invited to participate in an observational research study. The purpose of this study is to investigate diagnostic delay, symptom burden, psychological impact, and therapeutic expectations in patients with lipedema. The information collected will be used to improve clinical understanding and patient care for individuals with this condition.

3. Nature of Participation

Participation involves completing a structured questionnaire comprising 18 questions regarding your medical history, symptoms, psychological experience, and treatment preferences. Completion of the questionnaire takes approximately 10–15 minutes.

Participation is entirely voluntary. You may withdraw at any time without any consequence to your medical care.

4. Data Protection and Confidentiality

All data collected will be treated in strict accordance with the following:

• Italian Legislative Decree No. 196/2003 (Privacy Code) and its amendments
• EU General Data Protection Regulation (GDPR) No. 679/2016
• Italian Legislative Decree No. 101/2018

Your personal data (name, contact details) will be stored separately from your research responses. Only anonymised, aggregated data will be used in any scientific publication. Your identity will not be disclosed under any circumstances.

5. Risks and Benefits

This study involves no physical procedures, interventions, or biological samples. The only potential discomfort may arise from answering questions of a personal or psychological nature. Participation carries no known risks.

There is no direct benefit to participants from taking part in this study. However, your contribution will help advance scientific knowledge about lipedema and may ultimately benefit future patients.

6. Use of Data and Publication

Results of this study may be published in peer-reviewed scientific journals. No identifying information will be included in any publication. Data will be presented only in aggregate form.

7. Declaration of Consent

Please read each statement and indicate your agreement:

• I have read and understood the information provided about this study.
• I have had the opportunity to ask questions and have received satisfactory answers.
• I understand that my participation is voluntary and that I may withdraw at any time without consequence.
• I consent to the collection and processing of my personal data for the purposes described above, in accordance with applicable Italian and EU data protection legislation.
• I consent to the use of my anonymised data in scientific publications.
• I agree to participate in this observational study.