PD02-04: A Randomized, Prospective, Multicenter Study of the Impact of Intraoperative Margin Assessment with Adjunctive Use of MarginProbe vs. Standard of Care.

79 Background: Historically there has been a high rate of surgical interventions to obtain clear margins for breast cancer patients undergoing breast conserving local therapy. This study is the first compellation of data among three breast centers to assess the impact of an intraoperative margin assessment tool (MarginProbe) on re-excision rates. This device has been approved for clinical use in the United States since 2013. We present groups of consecutive patients in each of these breast centers – before and after the implementation of routine intraoperative use of the margin assessment device during lumpectomy procedures. Methods: Lesions were localized by standard methods. The intraoperative margin assessment device was used on all circumferential margins of the main specimen, but not on any additional shavings. A positive reading by the device led to an additional shaving of the corresponding cavity location. Specimens were also imaged intra-operatively by X-ray, and additional shavings were taken if needed based on clinical assessment. We established the historical re-excision rates of each surgeon on a consecutive set of patients in a corresponding period just before we began using the device. Results: In total, 165 patients were treated in three institutions up until April 2014. Sixteen patients (9.7%, 16/165) required re-excision. Historical re-excision rates corresponding to periods of use before the intraoperative margin assessment device was put into use were 25.8% (48/186). The re-excision rate was reduced by 62% (P<0.0001). Six re-excisions were due to a positive shaving which was not measured by the device. Conclusions: Use of an intraoperative margin assessment device contributes to achieving clear margins and reducing re-excision procedures. As in some cases positive margins were found on shavings, future studies of interest may include an analysis of the effect of using the device on the shavings intra-operatively.

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The impact of the Harmonic FOCUS™ on complications in thyroid surgery: a prospective multicenter study

Updates in Surgery ◽

10.1007/s13304-013-0223-2 ◽

2013 ◽

Vol 65 (4) ◽

pp. 295-299 ◽

Cited By ~ 11

Author(s):

Gabriele Materazzi ◽

Giuseppe Caravaglios ◽

Valeria Matteucci ◽

Aleksandr Aghababyan ◽

Mario Miccoli ◽

...

Keyword(s):

Multicenter Study ◽

Thyroid Surgery ◽

Prospective Multicenter Study ◽

Harmonic Focus ◽

The Impact

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The Impact of Ossification Spread on Cervical Spine Function in Patients With Ossification of The Posterior Longitudinal Ligament

10.21203/rs.3.rs-216266/v1 ◽

2021 ◽

Author(s):

Keiichi Katsumi ◽

Takashi Hirai ◽

Toshitaka Yoshii ◽

Satoshi Maki ◽

Kanji Mori ◽

...

Keyword(s):

Cervical Spine ◽

Multicenter Study ◽

Japanese Orthopaedic Association ◽

Posterior Longitudinal Ligament ◽

Multivariate Regression Analysis ◽

Adverse Outcomes ◽

Prospective Multicenter Study ◽

Spine Function ◽

Whole Spine ◽

The Impact

Abstract Ossification of the posterior longitudinal ligament (OPLL) is a progressive disease. The bridging of ossified lesions to the vertebral body gradually increases, thereby decreasing the mobility of the cervical spine; thus, cervical spine function may decrease over time. However, cervical spine function in patients with cervical OPLL has not been evaluated in large prospective studies. Therefore, we conducted a prospective multicenter study to clarify whether ossification spread can influence cervical spine function and quality of life (QOL) in patients with cervical OPLL. In total, 238 patients (162 men, 76 women; mean age, 63.9 years) were enrolled from 16 institutions. Each patient underwent whole spine computed tomography and was evaluated cervical spine function and QOL using the Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ). In the multivariate regression analysis, a higher neck VAS score and a larger number of bridge formations of OPLL in the whole spine were significant predictors of adverse outcomes related to cervical spine function. This is the first prospective multicenter study to reveal the impact of ossification spread on cervical spine function. These findings are important to understand the natural course of OPLL and can serve as controls when evaluating postoperative cervical spine function.

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