Senologie - Zeitschrift für Mammadiagnostik und -therapie 2015; 12 - A111
DOI: 10.1055/s-0035-1550552

Patient reported outcome measures (PROMs) in implant based mesh-supported breast reconstruction – early results of a multicenter prospective trial

S Paepke 1, M Kiechle 2, C Ankel 3, A Faridi 3, C Schumacher 4, A Meiré 4, C Mau 5, M Untch 6, K Baumann 7, C Gerber-Schäfer 8, J Blohmer 9, W Malter 10, M Dieterich 11, B Gerber 12, M Thill 13
  • 1München, Deutschland
  • 2Klinikum Rechts der Isar, Technische Universität München, Frauenklinik, München, Deutschland
  • 3Vivantes Klinikum Neuköln, Vivantes Brustzentrzum, Berlin, Deutschland
  • 4St. Elisbeth Krankenhaus Köln-Hohenlind, Brustzentrum, Köln, Deutschland
  • 5Helios Klinikum Berlin Buch, Frauenheilkunde, Berlin, Deutschland
  • 6Helios Klinikum Berlin Buch, Klinik für Gynäkologie und Geburtshilfe, Berlin, Deutschland
  • 7Universitätsfrauenklinik Schleswig Holstein, Klinik für Frauenheilkunde und Geburtshilfe, Lübeck, Deutschland
  • 8St. Gertrauden Krankenhaus, Brustzentrum City, Berlin, Deutschland
  • 9Charité, Klinik für Gynäkologie, Brustzentrum, Berlin, Deutschland
  • 10Uniklinik Köln, Klinik für Frauenheilkunde und Geburtshilfe, Köln, Deutschland
  • 11Klinikum Südstadt Rostock, Universitätsfrauenklinik und Poliklinik, Rostock, Deutschland
  • 12Klinikum Südstadt Rostock, Universitätsfrauenklinik und Poliklinik, Rostock, Deutschland
  • 13Agaplesion Markus Krankenhaus, Klinik für Gynäkologie und Geburtshilfe, Frankfurt am Main, Deutschland

Einleitung/Zielsetzung:

Since 2010 synthetic meshs and acellular dermal matrices are recommended for implant-coverage and fixation of the pectoralis muscle in the German guidelines. In the majority patients underwent implant-based reconstructive surgery with a titanized polypropylene mesh (TiloopBra®). Monoinstitutional experience and data of retrospective analysis (Dieterich, M) shows the procedure as safe and implemented in clinical routine. PROMs are increasingly used for the evaluation of surgical treatments in order to capture and quantify the impact of surgery on individual patients. The BreastQ (Pusic A; 2007) was implemented in PROMs of the reconstructive surgery strategies.

Material & Methoden:

For the PRO-Bra trial the planned patient recruitment number is 267 and trial initiation was in 01/2014. Focus of this prospective multicentre trial is the analysis of PROMs, independent review of cosmetic results, documentation of the complication rate and efficacy analysis.

Until 3/2014 120 pts in 10 centres were enrolled, 93 patients (122 mesh-interponations) were analyzed The basic procedures performed were 104 NSSM and 16 SSM.

Ergebnisse:

In 53.3% a unilateral and in 46.7% a bilateral mastectomy was performed: The complication rate observed at present is very low. In the majority of cases (8) a partial skin or areola-necrosis occurred. Furthermore 9 hematoma, 5 infections, 7 seroma and 1 implant-replacement were seen. 10% of the patients had a radiotherapy prior to the operation and 13% postop. In general the questionnaire analysis of patient reported cosmetic results showed 91% excellent and good, in 8% sufficient and 1% non sufficient ratings

Zusammenfassung:

The PRO-Bra-trial-results demonstrate a high acceptance of trial participants, high responsiveness and mostly excellent cosmetic results. In the era of personalized medicine PROMs have the potential to improve clinical decision-making and guide treatment recommandations by quantifying QoL and predicting patient satisfaction.