The 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.

The development of this study is led by the Brustzentrum Thurgau. Financial support is provided by Krebsliga Thurgau, Krebsliga Ostschweiz and private sponsors.

As of May 2023, the protocol was amended to version V6.0, and the sample size was increased from 360 to 455 patients. The 13 participating sites have recruited 363 of the now envisioned 455 patients (accrual 80%).

Every clinical trial has to be registered in a public register before starting patient recruitment. Please find here the link to the Irma Trial at ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT04390529