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Abstract SUMMARY ransurethral resection of bladder tumors (TURBT) using a wire loop still remains the gold-standard treatment for non-muscle invasive bladder cancer (NMIBC). The goal of any bladder tumor endoscopic approach is to make the correct diagnosis and to remove all visible lesions. On the other hand, the unacceptably high early recurrence rates after first resection as well as the significant complications of standard monopolar resection, consisting of bladder wall perforation, intra- and postoperative bleeding, urinary retention by clots, obturator nerve stimulation, tumoral spilling and urethral strictures also demanded the search for new alternatives. Bladder tumors characterized by specific features such as their location in places that are difficult to access (bladder dome, anterior bladder wall) or subject to obturator nerve stimulation (lateral bladder walls) as well as their size (larger than 3 cm) particularly imposed the search for surgical improvement. Bipolar electrosurgical techniques gathered increasing acknowledgement during the recent years, providing significant advantages in terms of improved hemostasis, decreased obturator nerve stimulation rate and good safety in patients with certain specific conditions such as anticoagulant therapy, cardiac pacemakers etc. The studies published during the recent years’ demonstrated the advantages of bipolar vaporization both in BPH and bladder tumors’ endoscopic procedures. Subjectively, this type of vaporization did not alter the visual characteristics of the anatomical layers, thus enabling the surgeon to differentiate the tumoral tissue, the muscular fibers of the bladder wall as well as the clear boundaries of the operating area with increased accuracy. Furthermore, although preliminary in this previous report, pathologic grade and staging information were not compromised despite the vaporization process. A total number of 50 cases that fit the inclusion criteria that will be admitted in the period between August 2012 and August 2014 will be enrolled in the study [An intervention study (Randomized controlled clinical trial)]. Patients will be equally divided into 2 groups, Group A will undergo TURBT and group B will undergo BPV-BT. All patients underwent a standard investigation protocol. The BPV-BT procedure started with a comprehensive cystoscopy, determining the presence, size and location of all existing tumors. The next step consisted of tumor biopsy performed with the same bipolar resectoscope and a thin resection loop, aiming to obtain a pathological specimen that would include tumoral tissue and the underlying muscle layer, in view of a complete pathological analysis. The main stage was represented by the actual plasma vaporization, during which the hemispherical shaped new type of electrode displaying a plasma corona on its surface was gradually moved in direct contact with the tumoral tissue. Tumor vaporization was applied until the muscular layer of the bladder wall was clearly exposed. Subsequently, the bipolar resection of the center and margins of the tumoral bed was performed for pathological confirmation of the complete tumor removal. As regards the TURBT arm, conventional monopolar transurethral resection of the bladder tumors was done using Storz 26 Fr continuous flow resectoscope with the hot loop electrode. Power was maintained at the default settings. Single immediate postoperative intravesical chemotherapy was given to all cases according to the EAU Guidelines unless bladder perforation is suspected after the TURBT or if significant hematuria is present. The sizes of the tumors was ranging from 2.5 to 5.5 cm with a mean size of 3.5 ± 0.87 cm for the TURBT group, whereas the BPV-BT group tumors sizes was ranging from 2.5 to 5.3 cm with a mean of 3.7 ± 0.83 cm. Intraoperative obturator nerve reflex occurred in 4 (16%) cases of the TURBT group while the BPV-BT group passed without experiencing such complication (0%). As regards the TURBT group, Intraoperative blood transfusion was ranging from 0 to 1 unit of packed RBCs with a median of 0 units, and was required only in 3 cases (12%), while no cases (0%) required Intraoperative blood transfusion in the BPV-BT group. Regarding Intraoperative perforation, it happened in 5 Cases (20%) of the TURBT group (A), 4 cases (16%) were extra peritoneal managed conservatively, 2 of them (50%) were due to intraoperative obturator nerve reflex and 1 case (4%) was intraperitoneal and managed surgically. Whereas the BPV-BT group (B) had no cases (0%) of intraoperative perforation. There was a statistically significant difference between both groups as regarding the mean change in sodium levels between the postoperative and the preoperative data in both groups (p = 0.005). And there was also a highly statistically significant difference between both groups as regarding the mean change in the hemoglobin levels between the postoperative and the preoperative data in both groups (p = 0.000). Postoperative hospital stay in the TURBT group (A), ranged from 1 to 6 days with a mean of 1.88 ± 1.16 days, whereas ranged from 1 to 3 days with a mean of 1.24 ± 0.52 days in the BPV-BT group (B). The catheter time was ranging from 1 to 14 days with a mean of 3.4 ± 3.8 days in the TURBT group (A) (prolonged due to perforations), while ranged from 1 to 10 days with a mean of 1.5 ± 1.8 days in the BPV-BT group (B) (prolonged only in one case due to iatrogenic urethral injury. The overall tumor recurrence, although numerically, whether at same site or another site was higher in the TURBT group (A) 15 recurrences to 8 recurrences in the BPV-BT group (B), still not yet statistically significant difference, and this may be attributed to the small sample size (p = 0.586). There was no statistically significant difference between both groups as regarding the tumor grade (p = 0.667), or stage (p = 0.755) progression. Finally, we may conclude that the bipolar plasma vaporization seems to represent a promising endoscopic treatment alternative for NMIBC patients, with good efficacy and reduced morbidity in cases of large bladder tumors. Longer follow up and larger sample sizes are needed to properly comment on the effect of BPV-BT on tumor recurrence and progression. |