Immediate Breast Reconstruction Following Mastectomy (IRMA) (IRMA)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer Female
• Intervention / Treatment: Other: quality-of-life questionnaire: BREAST-Q

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 515

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3001
    • Campus SLB Sonnenhof AG
  • Genève, Switzerland, 1205
    • HUG - Hôpitaux Universitaires de Genève
  • Zürich, Switzerland, 8091
    • Universitätsspital Zürich, Klinik für Gynäkologie
  • Aargau
    • Aarau, Aargau, Switzerland, 5001
      • Kantonsspital Aarau AG
    • Baden, Aargau, Switzerland, 5404
      • Kantonsspital Baden, Prof. Dr. med. Cornelia Leo
  • BE
    • Bern, BE, Switzerland, 3013
      • Brustzentrum Bern Biel, Hirslanden
  • GE
    • Chêne-Bougeries, GE, Switzerland, 1224
      • Centre du Sein de Genève - Hirslanden Clinique des Grangettes
  • SG
    • St. Gallen, SG, Switzerland, 9016
      • Brustzentrum Ostschweiz
  • Saint Gallen
    • St. Gallen, Saint Gallen, Switzerland, 9006
      • Tumor- und Brustzentrum ZeTuP
    • St. Gallen, Saint Gallen, Switzerland, 9016
      • Tumor- und Brustzentrum Ostschweiz
  • Thurgau
    • Frauenfeld, Thurgau, Switzerland, 8500
      • Brustzentrum Thurgau, Spital Thurgau AG, Prof. Dr. med. Mathias K. Fehr
  • Ticino
    • Lugano, Ticino, Switzerland, 6500
      • Ente Ospedaliero Cantonale (Ospedale Regionale di Bellinzona e Valli and Ospedale Regionale di Lugano)
  • ZH
    • Wetzikon, ZH, Switzerland, 8620
      • Spital Wetzikon
    • Zollikerberg, ZH, Switzerland, 8125
      • Brust Centrum Zürich, Bethanien & Zollikerberg
    • Zürich, ZH, Switzerland, 8063
      • Stadtspital Triemli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Women undergoing IRMA (NSM: nipple-areola sparing mastectomy or SSM: skin-sparing mastectomy) at any participating breast center may be included in the study. Patients undergoing IRMA for either prophylactic or oncologic purposes are eligible.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Thurgau Breast Center
• Investigators: Principal Investigator: Mathias Fehr, Prof. Dr., Brustzentrum Thurgau, Spital Thurgau AG

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2030

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 15, 2020

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: IRMA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No