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Sexual Well-being of Women Undergoing Mastectomy and Reconstruction

RecruitingNAAges 18 Years - anyFemaleEuropean Institute of Oncology
NCT07234461 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The study plans to collect data from patients on sexual well-being after mastectomy and immediate reconstruction by surveys. This data can support preoperative patient counselling and the prevention and care of adverse effects of cancer treatments. Specific subpopulations of mastectomy women showing severe sexual impairment can be outlined; they may benefit from lifestyle changes and intervention strategies (intravaginal use of diazepam, local hyaluronic acid, intravaginal use of spermidine, pelvic floor gymnastic and physiotherapy). Our goal is to improve quality of life of breast cancer patients.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients undergoing mastectomy for primary breast cancer; * High-risk healthy patients undergoing risk reducing mastectomies; * Unilateral and/or bilateral mastectomies; * If unilateral mastectomy, both patients requiring or not contralateral mammaplasty of the healthy breast; * All reconstructive procedures included (autologous and heterologous reconstructions). Exclusion Criteria: * Patients undergoing breast conservation; * Patients who previously underwent breast cancer treatment, requiring further surgery for local relapse or secondary breast cancers; * Delayed post-mastectomy reconstructions; * Patients not available for e-correspondence.
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What it tests

  • Survey using a questionnaire.
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Where

19 sites
Azienda Ospedaliero Universitaria Consorziale Policlinico
Bari, Italy
Istituto Tumori Giovanni Paolo II
Bari, Italy
Policlinico Sant'Orsola-Malpighi
Bologna, Italy
Ospedale Bufalini di Cesena
Cesena, Italy
Presidio Ospedaliero GB Morgagni-Pierantoni
Forlì, Italy
European Institute of Oncology
Milan, Italy
Ospedale Mater Olbia
Olbia, Italy
Azienda Ospedale Università di Padova
Padova, Italy

…and 11 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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