"PRO-Pocket"-Study
International prospective multicentre Post Market Clinical Follow Up to "Patient reported outcome" in primary or secondary breast reconstruction after mastectomy using a titanised polypropylene mesh (TiLOOP® Bra Pocket)
This international, multi-centre post market clinical follow up study will examine the titanised polypropylene mesh implant TiLOOP® Bra Pocket. TiLOOP® Bra Pocket is intended for the support, reinforcement and bridging of body's own tissue in reconstructive and plastic-aesthetic breast surgery, e.g. after breast cancer.
Study objectives
Primary Endpoint
- Assessment of quality of life after plastic-reconstructive surgery: comparison pre- and 12 months postoperative using the Breast-Q questionnaire reconstructive
Secondary Endpoint
- Recording of the quality of life after 6 and 24 months using the Breast-Q questionnaire reconstructive
- Documentation of the complication rate after 6, 12 and 24 months
- Evaluation of the cosmetic outcome after 6, 12 and 24 months with the use of photo documentation
Status of the study
Patient recruitment completed
Study centers
- Agaplesion Markus Krankenhaus, Frankfurt am Main
- DRK Kliniken Westend, Berlin
- GRN Klinik Weinheim
- Kliniken Essen Mitte
- Klinik für Frauenheilkunde und Brustzentrum, Universitätsmedizin Greifswald
- Klinikum rechts der Isar, München
- Rotkreuzklinikum München
- Sankt Gertrauden-Krankenhaus, Berlin
- Universitätsklinik für Frauenheilkunde Allgemeines Krankenhaus der Stadt Wien
- Universitätsklinikum Bonn
- Universitätsklinikum Heidelberg
- Universitätsklinikum Ulm
Independent expert to assess the cosmetic outcome
- Rems-Murr-Klinikum Winnenden
Further study details
Prepectoral reconstruction
Observational study on TiLOOP® Bra
A national, multicentre observational study on Patient Reported Outcome in breast reconstruction after mastectomy with titanised polypropylene mesh (TiLOOP® Bra) was conducted from 2013 to 2016.
Further information on the TiLOOP® Bra study
Contact
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