Immediate Breast Reconstruction Following Mastectomy (IRMA)

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a multicenter observational, cohort study. The study is designed to serve a similar purpose as a disease registry. The only study-specific intervention will be the completion of the BREAST-Q quality-of-life (QoL) form. Only quantitative data will be collected. The rationale for this study design is to identify and describe the type and frequency of complications related to IRMA. No hypothesis is being tested. Although group comparisons based on surgical techniques will be made, conclusions based on these findings will be limited by the observational nature of the design. Data from patients will be collected using a series of pseudonymized case report forms, including the validated quality-of-life questionnaire: BREAST-Q. These data will be entered into the web-based data collection system, SecuTrial. A precise description of the surgical procedure will be required, as specified on the case report forms (e.g., implantation of a mesh, resection margins), to allow for subsequent multivariate analyses. During the first year of follow-up, data from routine clinical assessments and the QoL forms will be gathered at baseline (within 90 days after mastectomy), 6 and 12 months. Thereafter, data will be collected from annual clinical assessments and completion of the QoL form will be done for an additional four years (24, 36, 48 and 60 months postoperatively). Consequently, a total of five years of postoperative follow-up data will be collected to allow sufficient time for the development of the majority of foreseeable complications.

Official Title
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A Multicenter, Observational Cohort Study of Women Undergoing Immediate Breast Reconstruction Following MAstectomy (IRMA)

Conditions
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Breast Cancer Female

Intervention / Treatment
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* Other: quality-of-life questionnaire: BREAST-Q


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: quality-of-life questionnaire: BREAST-Q|quality-of-life questionnaire: BREAST-Q|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of nipple-areola complex (NAC) or skin flap necrosis requiring specific treatment/surgery | Postoperative follow-up assessments include the documentation of nipple-areola complex (NAC) or skin flap necrosis | Three years after surgery | 
| Rate of infection requiring surgery | Postoperative follow-up assessments include the documentation of infections requiring surgery | Three years after surgery | 
| Grade of surgical complications | Postoperative follow-up assessments include the documentation of surgical complications (grading according to Clavien-Dindo Classification of Surgical Complications) | Three years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of minor complications not requiring surgery | Postoperative follow-up assessments include the documentation of skin necrosis outside NAC, wound dehiscence, and seroma requiring drainage | Three years after surgery | 
| Level of patient satisfaction with cosmesis | Postoperative follow-up assessment using BREAST-Q quality-of-life questionnaire that measures patient satisfaction with cosmetic outcome | Five years after surgery | 
| Level of sensitivity of the operated breast (NAC) compared to the non-operated breast | Postoperative follow-up assessments of breast functional outcomes | Five years after surgery | 
| Rate of breast cancer recurrence | Postoperative follow-up assessments include the documentation of recurrence in the NAC, skin flap outside the NAC, chest wall, locoregional lymph node (axillary, supraclavicular), distant metastasis | Five years after surgery |