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Clinical Trials in Germany / NCT04293146
Active, not recruiting Not applicable

Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy OPBC-02PREPEC

NCT04293146 · tracked via the Priya Life Science Germany tracker
Sponsor
University Hospital, Basel, Switzerland
Phase
Not applicable
Started
2020-07-28
Last updated
2024-12-13

Condition(s) studied

Breast ReconstructionImplant-Based Breast Reconstruction (IBBR)

Investigational drug(s) / intervention(s)

pre-pectoral IBBRsub-pectoral IBBR

pre-pectoral IBBR: The breast is reconstructed by positioning a breast implant above (pre-pectoral) the pectoralis major muscle.

sub-pectoral IBBR: The breast is reconstructed by positioning a breast implant below (sub-pectoral) the pectoralis major muscle.

Study summary

This trial is to investigate whether pre-pectoral Implant-Based Breast Reconstruction (IBBR) provides better Quality of Life (QoL) with respect to long-term (24 months) physical well-being (chest) compared to sub-pectoral IBBR for patients undergoing skin-sparing mastectomy or nipple-sparing mastectomy for prevention or treatment of breast cancer.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Written informed consent according to ICH/GCP regulations prior to any trial specific procedures * Patients undergoing NSM or SSM and IBBR in the therapeutic or risk-reducing Setting * Ability to complete the Quality of Life questionnaires Exclusion Criteria: * No indication for IBBR according to clinical judgment of the treating surgeon * Skin flaps inadequate for pre-pectoral IBBR.

Primary outcome measure(s)

  • Change in BREAST-Q scale — within 24 months after mastectomy (screening, day 10, and months 1, 6, 12 and 24)
    compare the Quality of Life (QoL) with respect to long-term physical well-being (chest) after pre-pectoral or sub-pectoral IBBR. The BREAST-Q module specific to breast reconstruction version 2.0 consists of 13 independent scales covering health-related QoL domains and satisfaction domains. Each scale is scored to generate a numerical score on a scale from 0 (worst) to 100 (best).
  • Change in EQ-5D-5L questionnaire — within 24 months after mastectomy (screening, day 10, and months 1, 6, 12 and 24)
    The 5-level version of the EQ-5D (EQ-5D-5L) consists of the EQ-5D descriptive system that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/Depression (5 answer levels each: no problems, slight problems, moderate problems, severe problems and extreme problems), resulting in a 1-digit number that expresses the level for that dimension. The digits for each dimension are combined into a 5-digit number that describes the patient's health state and is subsequently converted into a preference-based quality of life weight (utility) using an algorithm derived from population-based studies. In addition, patients are asked to rate their health on a vertical visual analogue scale (EQ VAS), where the anchors are labelled with 'The best health you can imagine' and 'The worst health you can imagine'.

Trial sites (22)

FacilityCityRegionStatus
Brigham and Women's Hospital Harvard Medical School Boston Massachusetts
Universitätsklinik für Frauenheilkunde und Geburtshilfe Salzburg Austria
Medizinische Universität Wien Vienna Austria
Evangelisches Krankenhaus BETHESDA zu Duisburg GmbH, Klinik für Frauenheilkunde, Geburtshilfe, Gynäkologische Onkologie & Senologie Duisburg Germany
KEM | Evang. Kliniken Essen-Mitte Essen Germany
Universitätsklinikum Heidelberg Heidelberg Germany
Landesfrauenklinik, Senologie und Brustzentrum Wuppertal Germany
National Institute of Oncology Budapest Hungary
Universitario "Agostino Gemelli" di Roma, Unità Operativa di Chirurgia Senologica Roma Italy
Ospedale Santa Chiara, Breast Surgical Oncology/Oncoplastic Surgery. Breast Center Trento Italy
Capio S:t Görans Hospital Stockholm Sweden
Södersjukhuset Stockholm Sweden
Karolinska University Hospital Stockholm Sweden
Klinik Hirslanden Brustzentrum Aarau Aarau Switzerland
Kantonsspital Aarau AG Aarau Switzerland
University Hospital Basel, Division of Breast Surgery Basel Switzerland
Universitätsklinik für Plastische- und Handchirurgie, Inselspital Bern Switzerland
Lindenhof Bern Bern Switzerland
Kantonsspital Frauenfeld Frauenfeld Switzerland
Gesundheitszentrum Fricktal Rheinfelden Switzerland
Ospedale Regionale di Lugano Viganello Switzerland
Brust-Zentrum Zürich Zurich Switzerland

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04293146 on ClinicalTrials.gov ↗ ← All trials in Germany