Clinical trial · Observational
Immediate Breast Reconstruction Following Mastectomy (IRMA)
A Multicenter, Observational Cohort Study of Women Undergoing Immediate Breast Reconstruction Following MAstectomy (IRMA)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| quality-of-life questionnaire: BREAST-Q | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Rate of nipple-areola complex (NAC) or skin flap necrosis requiring specific treatment/surgery
- timeFrame
- Three years after surgery
- description
- Postoperative follow-up assessments include the documentation of nipple-areola complex (NAC) or skin flap necrosis
- measure
- Rate of infection requiring surgery
- timeFrame
- Three years after surgery
- description
- Postoperative follow-up assessments include the documentation of infections requiring surgery
- measure
- Grade of surgical complications
- timeFrame
- Three years after surgery
- description
- Postoperative follow-up assessments include the documentation of surgical complications (grading according to Clavien-Dindo Classification of Surgical Complications)
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Any women ≥ 18 years of age undergoing IRMA (NSM or SSM) at any participating breast center may be included in the study. * Women undergoing IRMA for either prophylactic or oncologic purposes * Enrolment is possible up to 90 days after mastectomy * A patient who has had the mastectomy at a non-participating institution, but has subsequently sought treatment at one of the study centers, may be eligible for enrolment up to 90 days following mastectomy Exclusion Criteria: * Unwillingness to have follow-up assessments at the participating breast centers * Limited ability to understand study-specific procedures, which includes language difficulties.
References
Publications (0)
Data not yet available