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ACTIVE NOT RECRUITING
NCT04390529

Immediate Breast Reconstruction Following Mastectomy (IRMA)

Sponsor: Thurgau Breast Center

View on ClinicalTrials.gov

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

Interventions

OTHER

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