"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

TiLOOP® Bra Pocket

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

 

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