Francesco Micali

Electromotive instillation of mitomycin immediately before transurethral resection for patients with primary urothelial non-muscle invasive bladder cancer: a randomised controlled trial

BACKGROUND The clinical effect of intravesical instillation of chemotherapy immediately after transurethral resection of bladder tumours (TURBT) has recently been questioned, despite its recommendation in guidelines. Our aim was to compare TURBT alone with immediate post-TURBT intravesical passive diffusion (PD) of mitomycin and immediate pre-TURBT intravesical electromotive drug administration (EMDA) of mitomycin in non-muscle invasive bladder cancer. METHODS We did a multicentre, randomised, parallel-group study in patients with primary non-muscle invasive bladder cancer in three centres in Italy between Jan 1, 1994, and Dec 31, 2003. Patients were randomly assigned to receive treatment by means of stratified blocked randomisation across six strata. Patients and physicians giving the interventions were aware of assignment, but it was masked from outcome assessors and data analysts. Patients were randomly assigned to receive TURBT alone, immediate post-TURBT instillation of 40 mg PD mitomycin dissolved in 50 mL sterile water infused over 60 min, or immediate pre-TURBT instillation of 40 mg EMDA mitomycin dissolved in 100 mL sterile water with intravesical 20 mA pulsed electric current for 30 min. Our primary endpoints were recurrence rate and disease-free interval. Analyses were done by intention to treat. Follow-up for our trial is complete. This study is registered with ClinicalTrials.gov, number NCT01149174. FINDINGS 124 patients were randomly assigned to receive TURBT alone, 126 to receive immediate post-TURBT PD mitomycin, and 124 to receive immediate pre-TURBT EMDA mitomycin. 22 patients were excluded from our analyses because they did meet our eligibility criteria after TURBT: 11 had stage pT2 disease and 11 had carcinoma in situ. Median follow-up was 86 months (IQR 57-125). Patients assigned to receive EMDA mitomycin before TURBT had a lower rate of recurrence (44 [38%] of 117) than those assigned to receive PD mitomycin after TURBT (70 [59%] of 119) and TURBT alone (74 [64%] of 116; log-rank p<0·0001). Patients assigned to receive EMDA mitomycin before TURBT also had a higher disease-free interval (52 months, IQR 32-184) than those assigned to receive PD mitomycin after TURBT (16 months, 12-168) and TURBT alone (12 months, 12-37; log-rank p<0·0001). We recorded persistent bladder symptoms after TURBT in 18 (16%) of 116 patients in the TURBT-alone group (duration 3-7 days), 37 (31%) of 119 in the PD mitomycin post-TURBT group (duration 20-30 days), and 24 (21%) of 117 in the EMDA mitomycin pre-TURBT group (duration 7-12 days); haematuria after TURBT in eight (7%) of 116 patients in the TURBT-alone group, 16 (13%) of 119 in the PD mitomycin post-TURBT group, and 11 (9%) of 117 in the EMDA mitomycin pre-TURBT group; and bladder perforation after TURBT in five (4%) of 116 patients in the TURBT-alone group, nine (8%) of 119 in the PD mitomycin post-TURBT group, and seven (6%) of 117 in the EMDA mitomycin pre-TURBT group. INTERPRETATION Intravesical EMDA mitomycin before TURBT is feasible and safe; moreover, it reduces recurrence rates and enhances the disease-free interval compared with intravesical PD mitomycin after TURBT and TURBT alone. FUNDING None.

Remote telesurgical mentoring: feasibility and efficacy

We report our experience in performing telesurgically-mentored procedures from Baltimore, MD to Thailand, Austria, Italy and Singapore. We additionally report on a case of remote robotic manipulation using a robot designed for Percutaneons Access of the Kidney (PAKY). Telementoring was performed using a video teleconferencing platform including audio, video, real-time video telestration and remote control of the AESOP robotic arm that manipulates the laparoscopic camera. The international telementoring was achieved over 3- ISDN lines (384 Kilobytes/sec). The robotic arm and PAKY robot were controlled over a separate analog POTS line. Telecommunications links were successfully established to these remote locations that ranged in distance from approximately 4,500-11,000 miles. There was no perceptible impact of time delay on the surgical procedures. All procedures were successfully completed without additional complications. Multiple laparoscopic surgeries to include varicocelectomy (4), nephrectomy (4), adrenalectomy (1) and cholecystectomies (2) were demonstrated. Remote robotic percutaneous access to the kidney was successfully conducted within fifteen minutes from Baltimore, Maryland to Rome, Italy.

Posterior tibial nerve stimulation in the treatment of idiopathic nonobstructive voiding dysfunction.

OBJECTIVES To evaluate the effect of stimulation of the posterior tibial nerve in the treatment of voiding dysfunction. METHODS Thirty-nine patients with chronic voiding dysfunction necessitating clean intermittent catheterization were enrolled in a prospective multicenter trial in the Netherlands (n = 19) and Italy (n = 20). They underwent 12 weekly sessions of posterior tibial nerve stimulation. Frequency/volume charts, an incontinence quality-of-life instrument, and the MOS 36-item Short-Form Health Survey were completed at 0 and 12 weeks. Subjective success was defined by the patients positive response resulting in a request to continue treatment. Efficacy was based on analysis of the frequency/volume charts comparing the baseline values with the data at 12 weeks. A reduction of 50% or more in total catheterized volume was considered as an objective success (primary outcome measurement). RESULTS Of the 39 patients, 23 (59%) chose to continue treatment. The frequency/volume charts showed a 50% decrease in total catheterized volume in 16 (41%) of 39 patients. Additionally, 10 patients (26%) noted a reduction of 25% to 50% in their total catheterized volume. For all patients, the total catheterized volume decreased by a mean of -228 mL (range -49 to -528). The incontinence quality-of-life instrument and Short-Form Health Survey parameters improved significantly. CONCLUSIONS Percutaneous stimulation of the posterior tibial nerve seems to be an effective, minimally invasive option worth trying in patients with idiopathic voiding dysfunction. Improvement was seen in objective micturition parameters, as well as in subjective quality-of-life data.

RETROPERITONEAL LAPAROSCOPIC ACCESS IN CHILDREN USING A DIRECT VISION TECHNIQUE

PURPOSE Retroperitoneal procedures were initiated in 1992 by balloon dissection of the retroperitoneum. More recently a new type of retroperitoneal access has been obtained by directly entering the retroperitoneum using the Visiport visual trocar. We present our initial experience with direct visual access to the retroperitoneum in the pediatric population. MATERIALS AND METHODS A total of 31 children underwent retroperitoneal laparoscopy, including renal biopsy in 22, varicocelectomy in 5, renal cyst ablation in 3 and pyelolithotomy for a staghorn stone in 1. Patients were placed in the full flank position. A maximum of 3 ports was used and the initial trocar was placed under direct vision. The laparoscope was then used to dissect bluntly a working space in the retroperitoneum. RESULTS All procedures were successful. Blood loss was minimal. Operative time was 4 hours for pyelolithotomy and less than 1 for the other procedures. Mean hospital stay was 1.5 days and all patients returned to normal activity at a mean of 6 days. Two minor complications developed. The peritoneum was inadvertently entered in 1 case, in which no further treatment was necessary and convalescence was uneventful and short. In another case severe arrhythmia developed, resulting in an aborted procedure. CONCLUSIONS This technique is simple, safe and does not require extensive laparoscopic experience.

Retroperitoneal laparoscopy for renal biopsy in children

PURPOSE We report our experience with the retroperitoneal laparoscopic approach for treating pediatric patients and when the percutaneous needle approach is not possible due to uncontrolled hypertension, bleeding disorders, anti-clotting medications and anatomical abnormalities. MATERIALS AND METHODS Retroperitoneal laparoscopic renal biopsy was performed in 20 patients 2 to 18 years old (mean age 9.7) during a 16-month period. At the same time 53 percutaneous needle biopsies and 1 open biopsy were performed. The child is in a flank position, and 2 trocars are used via a direct vision approach. The first trocar is 12 mm. in diameter and positioned on the posterior axillary line, and the second trocar is 5 mm. in diameter and is entered 4 cm. anteriorly. Gentle dissection is done to free the lower pole of the selected kidney, biopsy forceps are used to grasp the specimen under direct vision and the biopsy site is fulgurated using bipolar electrocautery. RESULTS Biopsy was performed successfully in all cases except 1, which was converted to an open procedure. Mean operative time was 40 minutes, blood loss was minimal and mean hospital stay was 1.2 days postoperatively. No pain medication was required postoperatively, and all patients returned to their usual activities within 3 to 5 days. A minor intraoperative complication, which was a peritoneal tear with no postoperative sequelae, occurred in 1 case. CONCLUSIONS The retroperitoneal laparoscopic technique is simple and safe, and does not require extensive laparoscopic experience. We believe that this approach is reliable, and has less morbidity and several advantages compared to open surgery. It should be selected as the first choice for treating pediatric patients when percutaneous needle renal biopsy is contraindicated.

International Surgical Telementoring Using a Robotic Arm: Our Experience

To determine the clinical utility of delivering remote subspecialty surgical care using a novel telesurgical mentoring system with current telemedicine technology. A personal computer-based system ...

Prospects for radiofrequency hyperthermia applicator research. I – Pre-optimised prototypes of endocavitary applicators with matching interfaces for prostate hyperplasia and cancer treatments

Inconsistency is observed in comparing assessment data of applicators for endocavitary hyperthermia (EHT) with microwaves (MW) and radiofrequency (RF) obtained using the standard method of inserting bare applicators in phantom tissues. MW antennae exhibit overall average penetration depths of approximately 6 mm, excluding hot spots. RF radiators exhibit penetration depths of not more than approximately 3 mm, a value too low considering the superior penetration of the RF plane wave radiation. Assuming that a mismatch at the RF radiator–tissue interface is causing the poor energy transfer of RF energy, we developed new RF radiators with controlled dielectric matching interfaces for evaluating the potential of RF radiation in EHT and in interstitial hyperthermia (IHT) treatments. We designed, developed and assessed 27.12 MHz, 8 mm OD inductive and capacitive devices of novel and existing designs, each provided an optimised bi-layer matching interface. The assessment results reveal features such as customisable length and shape, independence of insertion depth, uncritical air gap, longitudinal heating uniformity, outstanding penetration depths (19–20 mm) and high SAR gradients at both radiator ends – i.e. prostatic urethra ends – for added safety. These data clear the way for the development of pre-optimised EHT inductive and capacitive RF applicators. Evidence of positive effects of high near-fields density in cavity microenvironments is given. Such devices show potential for more effective prostatic hyperplasia treatments and for improving the feasibility of more adequate treatment planning and thermal dosimetry of interstitial and transurethral hyperthermia treatments of prostate carcinoma.

Retroperitoneoscopy and Extraperitoneal Laparoscopy in Pediatric and Adult Urology

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Right varicocele associated with inferior vena cava malformation in situs inversus: Percutaneous treatment with retrograde sclerotherapy

Isolated right varicocele is a rare condition. It could be secondary to a retroperitoneal neoplastic mass involving the right internal spermatic vein, but sometimes, an anatomic variant must be considered. We present a case of a young man with situs inversus and right varicocele, a mirror image of the normal condition, associated with inferior vena cava malformation, who was treated successfully with retrograde selective percutaneous sclerotherapy of the right internal spermatic vein. Selective sclerotherapy of the internal spermatic vein at the time of venography has proved to be a valuable therapeutic option in right-sided varicocele associated with anatomic abnormalities.

Autologous Adrenal Medullary Transplant in Parkinson's Disease: Critical Review of Our Results in 13 Patients

Autotransplantation of the adrenal medullary to the caudate nucleus has been proposed for severe Parkinsons disease (PD). We describe our experience in 13 patients using a transperitoneal approach to the medullary and craniotomy for the implant: the neurosurgical equipes decision to opt for craniotomy made quick removal of the medullary with minimal morbidity more difficult. The surgical techniques are discussed. We evaluated also the impact of the procedure on urinary symptoms and sexual disturbances associated with PD. Results were disappointing. Four patients died post‐operatively. The neurological pattern improved in three men and one woman. No significant improvement was observed in the urological and sexual dysfunctions.