Status:
COMPLETED
Multimedia-assisted Informed Consent Procedure for Patients Undergoing Mastectomy and Implant-based Reconstruction
Lead Sponsor:
European Institute of Oncology
Conditions:
Breast Cancer
Eligibility:
FEMALE
Brief Summary
Breast reconstruction is a women's right with positive psychological effects and it is an integral part of breast cancer treatment and care. A preoperative counselling is mandatory, providing informat...
Detailed Description
Implant-based reconstruction is the most frequent procedure after mastectomy, able to preserve body integrity and femininity. Breast reconstruction is a women's right with positive psychological effec...
Eligibility Criteria
Inclusion
- Patients undergoing mastectomy for 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
Exclusion
- Patients undergoing mastectomy and autologous reconstruction
- Patients who previously underwent unilateral mastectomy and implant reconstruction, requiring contralateral mastectomy
- Patients not available for e-correspondence
Key Trial Info
Start Date :
January 2 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 25 2024
Estimated Enrollment :
265 Patients enrolled
Trial Details
Trial ID
NCT06541223
Start Date
January 2 2024
End Date
June 25 2024
Last Update
August 7 2024
Active Locations (1)
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1
European Institute of Oncology
Milan, Italy, 20141