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Active, Not Recruiting

NCT Number: NCT04390529

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Breast Cancer Female

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Ente Ospedaliero Cantonale (Ospedale Regionale di Bellinzona e Valli and Ospedale Regionale di Lugano), Lugano, Canton Ticino, Switzerland

Loading trial locations.

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

quality-of-life questionnaire: BREAST-Q

Other

quality-of-life questionnaire: BREAST-Q

Primary outcomes

  1. Rate of nipple-areola complex (NAC) or skin flap necrosis requiring specific treatment/surgery

    Time frame: Three years after surgery

    Postoperative follow-up assessments include the documentation of nipple-areola complex (NAC) or skin flap necrosis

  2. Rate of infection requiring surgery

    Time frame: Three years after surgery

    Postoperative follow-up assessments include the documentation of infections requiring surgery

  3. Grade of surgical complications

    Time frame: Three years after surgery

    Postoperative follow-up assessments include the documentation of surgical complications (grading according to Clavien-Dindo Classification of Surgical Complications)

Secondary outcomes

  1. Rate of minor complications not requiring surgery

    Time frame: Three years after surgery

    Postoperative follow-up assessments include the documentation of skin necrosis outside NAC, wound dehiscence, and seroma requiring drainage

  2. Level of patient satisfaction with cosmesis

    Time frame: Five years after surgery

    Postoperative follow-up assessment using BREAST-Q quality-of-life questionnaire that measures patient satisfaction with cosmetic outcome

  3. Level of sensitivity of the operated breast (NAC) compared to the non-operated breast

    Time frame: Five years after surgery

    Postoperative follow-up assessments of breast functional outcomes

  4. Rate of breast cancer recurrence

    Time frame: Five years after surgery

    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

Sponsors and collaborators

Lead sponsor

Thurgau Breast Center

Other

Registry information

Official study title

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

Acronym: IRMA

Important dates

Study start
2018
Primary completion
2030
Study completion
2030
First posted
May 15, 2020
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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