Dinneen, E;
Haider, A;
Grierson, J;
Freeman, A;
Oxley, J;
Briggs, T;
Nathan, S;
... Shaw, G; + view all
(2020)
NeuroSAFE frozen section during robot-assisted radical prostatectomy (RARP): Peri-operative and Histopathological Outcomes from the NeuroSAFE PROOF Feasibility Randomised Controlled Trial.
BJU International
, 127
(6)
pp. 676-686.
10.1111/bju.15256.
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Abstract
Objectives: To report on the methods, peri‐operative outcomes and histopathological concordance between frozen and final section from the NeuroSAFE PROOF Feasibility study (NCT03317990). Patients and Methods: Between May 2018 and March 2019 49 men at 2 UK centres underwent robot‐assisted robotic prostatectomy (RARP). 25 men were randomised to NeuroSAFE RARP (intervention arm) vs. 24 men to standard RARP (control arm). Frozen section was compared to final paraffin section margin assessment in the 25 men in the NeuroSAFE arm. Operation timings and complications were collected prospectively in both arms. Results: 50 NVB from 25 patients in the NeuroSAFE arm were analysed. When analysed by each pathological section (n=250, average 5 per side) we note sensitivity 100%, specificity 99.2%, AUC was 0.994 (95% CI 0.985 to 1, P= <.001). On an NVB basis (n=50) we note sensitivity of 100%, specificity 92.7%, and AUC of 0.963 (95% CI 0.914 to 1, p = <0.001. NeuroSAFE RARP lasted a mean 3 hours 16 minutes (knife to skin to off table, 95% CI 3 hrs 2 mins ‐ 3 hrs 30 mins) compared to 2 hours 14 minutes (2 hrs 2 mins ‐ 2 hours 25 mins, P=<0.001) for standard RARP. There was no morbidity associated with the additional length of operation in the NeuroSAFE arm. Conclusion: This feasibility study demonstrates the safety, the reproducibility and the excellent histopathological concordance of the NeuroSAFE technique in the NeuroSAFE PROOF trial. Though the technique increases the duration of RARP, this does not cause short‐term harm. Confirmation of feasibility has led to the opening of the fully powered NeuroSAFE PROOF RCT, which is currently underway at 4 sites in the UK.
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