Brief description of trial (Data source: BASEC)
Die Studie untersucht, ob bei einer Mastektomie mit direkter Brustrekonstruktion die Implantat-Position vor oder hinter dem Brustmuskel besser für die Patientinnen ist.
Health conditions investigated(Data source: BASEC)
Brustrekonstruktion nach einer Mastektomie
Health conditions
(Data source: WHO)
Breast Reconstruction;Implant-Based Breast Reconstruction (IBBR)
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Implantat-Position vor oder hinter dem Brustmuskel.
Interventions
(Data source: WHO)
Procedure: pre-pectoral IBBR;Procedure: sub-pectoral IBBR
Criteria for participation in trial
(Data source: BASEC)
1. Eine unterschriebene Einverständnisserklährung liegt vor.
2. Patienten älter als ≥ 18 Jahre.
3. Patienten welche sich brustwarzenerhaltende Mastektomie oder hautsparende Mastektomie und Rekonstruktion der Brüsten mittels Implantaten als Therapie oder zur Risikoreduktion unterziehen.
4. Fähig die Fragebögen auszufüllen.
Exclusion criteria
(Data source: BASEC)
Exclusion criteria:
1. Keine Indikation für eine Rekonstruktion der Brüsten mittels Implantaten anhand des Urteils des behandelnden Chirurgen.
2. Hautlappen ( Hautdicke, Durchblutung) unpassend für die Positionierung des Implantats vor dem Brustmuskel
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender: Female
Maximum age: N/A
Minimum age: 18 Years
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.
-
Further information on trial
Recruitment status
Active, not recruiting
Academic title
(Data source: WHO)
Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy (OPBC-02/ PREPEC): A Pragmatic, Multicenter, Randomized, Superiority Trial
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Single (Outcomes Assessor).
Phase
(Data source: WHO)
N/A
Primary end point
(Data source: WHO)
Change in BREAST-Q scale;Change in EQ-5D-5L questionnaire
Secundary end point
(Data source: WHO)
loss of expander or implant;surgical complications;thromboembolic events;patient satisfaction;animation deformity;capsular contracture;aesthetic results;Recurrence-free survival (RFS);aesthetic results evaluated by patients;total number of operative procedures;length of hospital stay (index hospitalization and overall);total number of outpatient visits at the trial site and the emergency department;aesthetic results evaluated by local physicians
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Aarau, Basel, Bern, Frauenfeld, Lugano, Münsterlingen, St. Gallen, Zurich
Countries
(Data source: WHO)
Austria, China, Germany, Hungary, Italy, Sweden, Switzerland, United States
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Prof. Dr. med. Walter P. Weber
+41 61 328 61 49
walter.weber@usb.ch
Contact for general information
(Data source: WHO)
Walter Weber, Prof. Dr. med
Division of Breast Surgery, University Hospital Basel
Contact for scientific information
(Data source: WHO)
Walter Weber, Prof. Dr. med
Division of Breast Surgery, University Hospital Basel
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
Date of authorisation by the ethics committee
27.03.2020
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2020-00256
Secondary ID (Data source: WHO)
ch18Weber4
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