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First Results Of A Pre-planned Interim Analysis Of A National Multicenter Patient Reported Outcome Study (PRO-Bra) In Breast Reconstruction Following Mastectomy With Titaniferously Coated Polypropylene Mesh (TiloopBra) | 66957
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First results of a pre-planned interim analysis of a national multicenter patient reported outcome study (PRO-Bra) in breast reconstruction following mastectomy with titaniferously coated polypropylene mesh (TiloopBra)
Introduction: In the majority of interdisciplinary breast centers of Germany implant based, mesh-supported operations
constitute a total of approximately 50-60% of reconstructive techniques. The BreastQ is the most valid and reliable measurement
of quality of life aspects in important domains used in clinical routine.
Material & Method: Because the patient reported outcome is the most relevant factor reflecting the overall satisfaction from
a patient perspective a prospective surveillance study with BreastQ-scales at 12 months as primary endpoint was conducted
(2013) and ended 7/2016 with full recruitment (n=267). A pre-planned analysis of the first 60 pts with completion of the
BreastQ after 6 months was done.
Results: Almost all surgeries were primary reconstructions (96.6%) and nipple-skin-sparing mastectomies (97.1%). The
most frequent incision was inframammary (n=115), followed by T-shaped (n=45). The average of the pts was 50 y (19-77),
BMI was 22 (17-33), 77.3% were non-smokers. Percentage of neoadjuvant chemotherapy was 23% of prior radiotherapy was
12%. Radiotherapy showed no significant influence of the BreastQ. Severe events occurred in 46 cases. The most frequent
complications were necrosis (n=12), hematoma (n=12) and 9 pts were dropped out. The mean score of BreastQ was equal
pre and postoperative after 6 months (67+/-16 to 65+/-15) satisfaction with breast from 67+/-22 to 61 +/-14; psycho-social
well-being from 71+/-17 to 73+/-18, sexual well-being from 62+/-17 to 60+/-19, satisfaction with outcome was 75+/-18 and
satisfaction with surgeon 90+/-15. 88.3% were very satisfied, 10.0% somewhat satisfied, only 1.7% somewhat dissatisfied and
0% very dissatisfied.