IRMA Trial

 

IRMAThe IRMA Study is a multicenter observational cohort study of women undergoing immediate breast reconstruction following either prophylactic mastectomy or mastectomy due to breast cancer.

The aim of immediate breast reconstruction following mastectomy (IRMA) is to rebuild the shape and appearance of the removed breast. IRMA includes skin-sparing mastectomy (SSM) and nipple-areola sparing mastectomy (NSM). Based on data from the US Surveillance, Epidemiology and End Result Program (SEER), NSM rates have risen 202% since 2009. Despite the increasing popularity of immediate breast reconstruction, limited prospective studies have been done to identify risk factors for complications. Of particular importance is to assess the effects of combining the procedure with radiotherapy, and undergoing a one- versus two-step surgical procedure.

This study's primary objective is to track prospectively postoperative complications, tumor recurrence as well as quality of life and body image among patients undergoing IRMA (skin-sparing mastectomy or nipple-areola sparing mastectomy).

By actively monitoring these patients, we aim to identify an optimal strategy for IRMA that may lead to the development of clinical guidelines, which are currently lacking.

Join in!

The development of this study is led by the Brustzentrum Thurgau. Financial support has been provided by the Krebsliga Thurgau and private sponsors. As of January 4, 2021, 90 of 360 patients have been enrolled in the study.

ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT04390529

Address

Swiss GO Trial Group
Gynecological Oncology
Hospital for Women
University Hospital Basel
Spitalstrasse 21
CH-4031 Basel
Switzerland

Contact Info

Phone: +41 61 265 75 00
Fax:      +41 61 265 93 22

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