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Immediate Breast Reconstruction Following Mastectomy (IRMA)
Sponsor: Thurgau Breast Center
Summary
Based on data from the US Surveillance, Epidemiology and End Result Program (SEER), the rates of nipple-sparing mastectomy (NSM) have risen 202% since 2009. In spite of the increasing popularity of IRMA, limited research has been done to identify complications in patients undergoing these procedures. Of particular importance is to assess the effects of combining the procedure with radiotherapy, and undergoing a one- versus two-step surgical procedure. Active monitoring and periodic assessment of IRMA patients are needed to establish the safety of these different techniques in terms of complications and recurrence rates. Identifying an optimal strategy for IRMA may lead to the development of clinical guidelines, which are currently lacking.
Official title: A Multicenter, Observational Cohort Study of Women Undergoing Immediate Breast Reconstruction Following MAstectomy (IRMA)
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
515
Start Date
2018-01-01
Completion Date
2030-04-30
Last Updated
2025-05-15
Healthy Volunteers
Not specified
Conditions
Interventions
quality-of-life questionnaire: BREAST-Q
quality-of-life questionnaire: BREAST-Q
Locations (15)
Kantonsspital Aarau AG
Aarau, Canton of Aargau, Switzerland
Kantonsspital Baden, Prof. Dr. med. Cornelia Leo
Baden, Canton of Aargau, Switzerland
Brustzentrum Bern Biel, Hirslanden
Bern, Canton of Bern, Switzerland
Centre du Sein de Genève - Hirslanden Clinique des Grangettes
Chêne-Bougeries, Canton of Geneva, Switzerland
Tumor- und Brustzentrum ZeTuP
Sankt Gallen, Canton of St. Gallen, Switzerland
Brustzentrum Ostschweiz
Sankt Gallen, Canton of St. Gallen, Switzerland
Tumor- und BrustZentrum Ostschweiz
Sankt Gallen, Canton of St. Gallen, Switzerland
Spital Wetzikon
Wetzikon, Canton of Zurich, Switzerland
Brust Centrum Zürich, Bethanien & Zollikerberg
Zollikerberg, Canton of Zurich, Switzerland
Stadtspital Triemli
Zurich, Canton of Zurich, Switzerland
Ente Ospedaliero Cantonale (Ospedale Regionale di Bellinzona e Valli and Ospedale Regionale di Lugano)
Lugano, Canton Ticino, Switzerland
Brustzentrum Thurgau, Spital Thurgau AG, Prof. Dr. med. Mathias K. Fehr
Frauenfeld, Thurgau, Switzerland
Campus SLB Sonnenhof AG
Bern, Switzerland
HUG - Hôpitaux universitaires de Genève
Geneva, Switzerland
Universitätsspital Zürich, Klinik für Gynäkologie
Zurich, Switzerland