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JOURNAL ONKOLOGIE – STUDIE
IRMA

Immediate Breast Reconstruction Following Mastectomy (IRMA)

Rekrutierend

NCT-Nummer:
NCT04390529

Studienbeginn:
Januar 2018

Letztes Update:
08.06.2023

Wirkstoff:
-

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Thurgau Breast Center

Collaborator:
-

Studienleiter

Mathias Fehr, Prof. Dr.
Principal Investigator
Brustzentrum Thurgau, Spital Thurgau AG

Kontakt

Studienlocations
(3 von 15)

Kantonsspital Aarau AG
5001 Aarau
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Dimitri Sarlos, PD Dr. med.
E-Mail: dimitri.sarlos@ksa.ch

Vasiliki Gorgorini, Dr. med.
E-Mail: vasiliki.gorgorini@ksa.ch» Ansprechpartner anzeigen
Brustzentrum Bern Biel, Hirslanden
3013 Bern
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Patrizia Sager, Dr.
E-Mail: Patrizia.Sager@hirslanden.ch

Silvia Andrist
Phone: 0041 31 337 89 69
E-Mail: Silvia.Andrist@hirslanden.ch» Ansprechpartner anzeigen
Centre du Sein de Genève - Hirslanden Clinique des Grangettes
1224 Chêne-Bougeries
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Anne-Patricia Brunelli Roche, Dr.
E-Mail: patricia.brunelli@bluewin.ch

Ashley Machen
Phone: 0041 22 545 28 73
E-Mail: ashley.machen@grangettes.ch» Ansprechpartner anzeigen
Tumor- und Brustzentrum ZeTuP
9006 St. Gallen
SwitzerlandAbgeschlossen» Google-Maps
Tumor- und BrustZentrum Ostschweiz
9016 St. Gallen
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Rahel Hiltebrand, Dr. med.
E-Mail: rahel.hiltebrand@tbz-ost.ch

Claudia Frey
E-Mail: claudia.frey@tbz-ost.ch» Ansprechpartner anzeigen
Brustzentrum Ostschweiz
9016 St. Gallen
SwitzerlandAbgeschlossen» Google-Maps
Brustzentrum Thurgau, Spital Thurgau AG, Prof. Dr. med. Mathias K. Fehr
8500 Frauenfeld
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
JoEllen Welter, MPH
Phone: 0041 52 723 72 56
E-Mail: joellen.welter@stgag.ch» Ansprechpartner anzeigen
Ospedale Regionale Bellinzona e Valli, Dr. Begoña Lipp von Wattenwyl
6500 Bellinzona
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Begoña Lipp von Wattenwyl, Dr.
Phone: 0041 91 811 9438
E-Mail: BegonaMaria.LippVonWattenwyl@eoc.ch» Ansprechpartner anzeigen
Spital Wetzikon
8620 Wetzikon
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Denise Beck, Dr.
E-Mail: denise.beck@gzo.ch

Marta Bachmann
Phone: 0041 44 934 28 49
E-Mail: marta.bachmann@gzo.ch» Ansprechpartner anzeigen
Brust Centrum Zürich, Bethanien & Zollikerberg
8125 Zollikerberg
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Hisham Fansa, Prof. Dr.
E-Mail: hisham.fansa@spitalzollikerberg.ch

Irene Brenneisen
Phone: 0041 44 397 24 01
E-Mail: irene.brenneisen@spitalzollikerberg.ch» Ansprechpartner anzeigen
Stadtspital Triemli
8063 Zürich
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Heike Passmann, Dr.
Phone: 0041 44 416 11 11
E-Mail: Heike.Passmann@triemli.zuerich.ch

Barbara Herzog
E-Mail: Barbara.Herzog@triemli.zuerich.ch» Ansprechpartner anzeigen
Campus SLB Sonnenhof AG
3001 Bern
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Yves Brühlmann, Dr.
Phone: 0041 31 309 95 30
E-Mail: yves.bruehlmann@plast.ch

Cindy Groen
E-Mail: cindy.groen@lindenhofgruppe.ch» Ansprechpartner anzeigen
Universitätsspital Zürich, Klinik für Gynäkologie
8091 Zürich
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Heike Frauchiger-Heuer, Dr.
Phone: 0041 44 255 52 00
E-Mail: heike.frauchiger-heuer@usz.ch

Isabel Breyer
E-Mail: Isabel.breyer@usz.ch» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

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 outcome:

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

Geprüfte Regime

  • quality-of-life questionnaire: BREAST-Q:
    quality-of-life questionnaire: BREAST-Q

Quelle: ClinicalTrials.gov


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