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Immediate Breast Reconstruction Following Mastectomy (IRMA)

NCT04390529 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 515

Last updated 2025-05-15

No results posted yet for this study

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.

Conditions

  • Breast Cancer Female

Interventions

OTHER

quality-of-life questionnaire: BREAST-Q

quality-of-life questionnaire: BREAST-Q

Sponsors & Collaborators

  • Thurgau Breast Center

    lead OTHER

Principal Investigators

  • Mathias Fehr, Prof. Dr. · Brustzentrum Thurgau, Spital Thurgau AG

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2030-04-30
Completion
2030-04-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04390529 on ClinicalTrials.gov