Premium
Chitosan membranes applied on the prostatic neurovascular bundles after nerve‐sparing robot‐assisted radical prostatectomy: a phase II study
Author(s) -
Porpiglia Francesco,
Bertolo Riccardo,
Fiori Cristian,
Manfredi Matteo,
De Cillis Sabrina,
Geuna Stefano
Publication year - 2018
Publication title -
bju international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 1464-4096
DOI - 10.1111/bju.13959
Subject(s) - neurovascular bundle , prostatectomy , urology , membrane , materials science , chitosan , medicine , biomedical engineering , prostate , chemistry , surgery , cancer , biochemistry
Objective To evaluate the feasibility and the safety of applying chitosan membrane (ChiMe) on the neurovascular bundles ( NVB s) after nerve‐sparing robot‐assisted radical prostatectomy ( NS ‐ RARP ). The secondary aim of the study was to report preliminary data and in particular potency recovery data. Patients and Methods This was a single‐centre, single‐arm prospective study, enrolling all patients with localised prostate cancer scheduled for RARP with five‐item version of the International Index of Erectile Function scores of >17, from July 2015 to September 2016. All patients underwent NS ‐ RARP with ChiMe applied on the NVB s. The demographics, perioperative, postoperative and complications data were evaluated. Potency recovery data were evaluated in particular and any sign/symptom of local allergy/intolerance to the ChiMe was recorded and evaluated. Results In all, 140 patients underwent NS ‐ RARP with ChiMe applied on the NVB s. Applying the ChiMe was easy in almost all the cases, and did not compromise the safety of the procedure. None of the patients reported signs of intolerance/allergy attributable to the ChiMe and potency recovery data were encouraging. Conclusion In our experience, ChiMe applied on the NVB s after NS ‐ RARP was feasible and safe, without compromising the duration, difficulty or complication rate of the ‘standard’ procedure. No patients had signs of intolerance/allergy attributable to the ChiMe and potency recovery data were encouraging. A comparative cohort would have added value to the study. The present paper was performed before Conformité Européene ( CE )‐mark achievement.