V8-02: APPLICATION OF CHITOSAN MEMBRANES ON THE NEUROVASCULAR BUNDLES AFTER ROBOT-ASSISTED RADICAL PROSTATECTOMY: PRELIMINARY RESULTS OF A PHASE II STUDY
A physical damage can occur to the neurovascular bundles during the procedure, due to the use of cautery and tractions.Nowadays bio-engineeringis developing novel devices with the aim of co-operate the neural renewal.Among them chitosan seems to be promising with neuro-regenerative properties. In our Institution we tried to use chitosan membranes as scaffold for neural renewal after nerve-sparingrobot-assisted radical prostatectomy (RARP)._x000D_ In laboratory setting results were promising so we designed a prospectivestudytrying to confirmchitosanproperties in_x000D_ clinicalpractice._x000D_ Primary end-point: to evaluate the feasibility of the application of chitosan membrane on neuro-vascular bundles after nerve-sparing RARP. Secondary end-point: To evaluate the recovery of erectile function at 1, 2, and 3 months postoperatively by performing a matched-pair analysis comparing the group of patients who underwent chitosan application to a control group who did not.
47patients who underwent nerve sparingRARP (07/2015 - 01/2016) were enrolled. Criteria for inclusion was an IIEF>17._x000D_ A control group of patients was selected. Potency recovery was defined as erection enough for intercourse or masturbation._x000D_ Membranes were adequately prepared by immersion in saline solution and cutting. After that reconstructive phase of RARP was performed,chitosan membranes were introduced and applied on the bundles.
Baseline data of patients in the Groups were comparable.Concerning intraoperative data, no modifications of operative time was recorded in the Chitosan Group;No intraoperative complications occurred.Postoperative complications rate was not affected by the application of the membrane.Concerning the functional data, a faster erectile function recovery was recorded in the cohort of patients who underwent chitosan application.
In our experience, the application of chitosan membranes on the neurovascular bundles after robot-assisted RP was easy and safe. Preliminary functional outcomes showed a faster recovery of erectile function in the cohort of patients who underwent the application of the membranes.Larger sample size and randomized trials are needed in order to confirm these preliminary outcomes.