A. García-Tello

Safety Study of Umbilical Single-port Laparoscopic Radical Prostatectomy with a New DuoRotate System

BACKGROUND Laparoendoscopic single-site (LESS) radical prostatectomy (RP) has been performed through different approaches. A new DuoRotate manual system developed by Richard Wolf (KeyPort; Richard Wolf GmbH, Knittlingen, Germany) can be applied to RP. OBJECTIVES Our aim was to describe the surgical technique and report early outcomes of KeyPort LESS-RP to determine if this procedure is feasible and safe. DESIGN, SETTING, AND PARTICIPANTS Prospective study performed between October 2011 and January 2012 to standardize LESS-RP. A total of 31 procedures were performed (10 with and 21 without neurovascular preservation, 8 with and 23 without pelvic lymph node dissection). SURGICAL PROCEDURE LESS-RP was performed using the methods outlined in the manuscript. All patients underwent LESS RP by the same surgical team. Access was achieved via a tri-channel reusable KeyPort and one 3.5-mm extra port to facilitate urethrovesical anastomosis and drainage extraction. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Preoperative, perioperative, and pathologic outcomes data are presented. RESULTS AND LIMITATIONS The mean age of the patients was 64 yr; mean body mass index: 30.7 kg/m(2); mean prostate-specific antigen level: 7 ng/ml; mean operative time: 207 min; and mean estimated blood loss: 258 ml. The average length of stay was 2.9 d and visual analog pain score (range: 0 [no pain] to 10) at day 2 was 1.2. Five focal positive margins (16.7%) were encountered (4.4% for pT2 and 57.1% for pT3). Five cases (16.7%) were pT2a, 3 (10%) were pT2b, 15 (50%) were pT2c, and 7 (23.3%) were pT3a. Lymph node dissection results were negative in all patients. Major complications occurred in two patients (6.5%) (hypercapnia with respiratory acidosis and rectourethral fistula) and minor complications in four (12.9%) (atrial fibrillation, orchitis, transfusion, and vomiting). No case required additional analgesia. Incision was totally hidden in the umbilicus. Study limitations included short follow-up (mean: 20.2 ± 4.1 wk), premature functional data, and absence of a comparative cohort. CONCLUSIONS The KeyPort system allows performance of umbilical RP with few complications, a low positive-margin rate, excellent aesthetic results, and very low postoperative pain levels.

The Value of C-reactive Protein Determination in Patients With Renal Colic to Decide Urgent Urinary Diversion

OBJECTIVES To analyze whether C-reactive protein (CRP) predicts the need for urgent urinary diversion in patients with renal colic and urolithiasis. CRP may help in the differential diagnosis of complicated hydronephrosis. METHODS Prospective study done on 110 consecutive patients with renal colic secondary to upper urinary tract calculi admitted in the emergency room. Clinical and analytical data were collected. Criteria for emergency drainage had been established in advance, based on the risk of sepsis, renal failure, persistence of pain, and findings on computed tomography scan. CRP was blindly determined using immunoturbidimetric assay on the Integra 700 analyzer. Statistical analysis included Mann-Whitney test, Cox multivariate analysis, and receiver operating characteristic curves, to determine optimum cut-off points to decide drainage based on laboratory data. RESULTS Mean CRP value was 47.6 mg/L (CI, 31.4-63.8), 139.6 mg/L (CI, 13-183.1) in 29 patients treated with diversion and 14.67 mg/L (CI, 6.7-22.5) in the control group (P <.001). Age, sex, rate of patients with hypertension, history of cardiovascular disease, leukocyte total count, and serum creatinine differed between groups (P <.05). Regression analysis revealed CRP (P <.0001) and age (P = .0001) were predictive of urinary diversion. Receiver operating characteristic analysis revealed 68.4% area under the curve for creatinine, 68.8% for leukocytosis, and 86.8% for CRP. A cut-off point for CRP of 28 mg/L achieved optimum sensitivity (75.8%) and specificity (88.9%) for determining the decision for drainage. CONCLUSIONS Determination of CRP in patients with renal colic due to urolithiasis provides an objective and useful parameter for deciding placement of urinary stent, which is even more valuable than leukocytosis or seric creatinine level.

Eficacia y seguridad de fosfomicina-trometamol en la profilaxis de la biopsia transrectal de la próstata: estudio prospectivo aleatorizado comparativo con ciprofloxacino

OBJECTIVE Prostate biopsy is the standardized diagnostic method for prostate cancer. However, although there is not a standardized protocol, there are recommendations in order to reduce the incidence of complications. The objective of the present work is to assess the efficacy and safety of antibiotic prophylaxis in the prostate biopsy by comparing two antibiotic regimes: two doses of fosfomycin-trometamol 3g (FMT) every 48 hours with 10 doses of oral ciprofloxacin 500 mg every 12 hours during 5 days. MATERIAL AND METHODS Randomized prospective study was performed with 671 patients who had undergone to walking transrectal ultrasound guided prostate biopsy. Patients of group A (n=312) were treated with ciprofloxacin, and patients of group B (n=359) with FMT. Efficacy and tolerability of two prophylactic regimes were compared. Urine culture was carried out at 2 weeks after biopsy. Initially, patients with asymptomatic bacteriuria were not treated with antibiotics; urine culture was repeated after 1 month, persistent bacteriuria was treated according to antibiogram. RESULTS No differences between groups were found in age (P=.78), cancer presence (P=.9) or number of biopsy cylinders (P=.93). The mean number of cores obtained was 11.3 ± 3.25 (range 6-20). Digestive intolerance was observed for 9 patients (2.9%) of group A and 10 patients (2.8%) in group B. One patient (.3%) of group A showed severe allergic reaction. In total, 167 patients (24.6%) had complications: 16 (2.4%) fever, 47 (6.9%) hemospermia, 81 (11.9%) hematuria, 7 (1%) rectal bleeding and 16 (2.4%) urinary retention. No statistically differences between groups were observed (27.6% vs. 22.6%; P=.17). However, hemospermia was more frequent in group A (9.9% vs. 4.5%; P=.006). Bacteriuria after biopsy was detected in 44 patients (6.6%), being more frequent in group B patients (4.2% vs. 8.6%; P=.02) although a higher number of second treatment cycles were not needed (53.9% vs. 29%; P=.17). The likelihood of resistance to ciprofloxacin in patients with bacteriuria in A was greater than that of FMT in B (69.2% vs. 41.9%; P=.0004). CONCLUSIONS Antibiotic prophylaxis with FMT (2 doses of 3g) in prostate biopsy is an alternative as effective and safe as ciprofloxacin (10 doses of 500 mg), which carries lower rate of resistance. According to our experience, this drug is a safe, well-tolerated, and easily manageable prophylactic option, facilitating patient compliance. More prospective multicenter studies are necessary to confirm these findings.

Puesta en marcha de un programa de entrenamiento para laparoscopia urológica por puerto único

OBJECTIVES To describe the onset of a single port laparoendoscopic program to carry out oncology surgery in a Urology Service. We present the initial experience in the laboratory and in the Animal Facility with rigid precurved instruments and KeyPort reusable access element (Richard Wolf). MATERIAL AND METHODS Two surgeons experienced in laparoscopic surgery and with the help of four assistants performed a training program based on predetermined tasks performed in simulation boxes (pelvitrainer) and porcine model following the requirements of the Regional Community of Madrid to handle experimental animals. RESULTS The participants in this program were initially divided into pairs made up of an experienced surgery and assistant for the predetermined multiple tasks in simulator box in order to become familiarized with the instruments. After, 20 animal sessions were conducted in which the following were performed: (retroperitoneal or pelvic) lymph node dissections (n = 20), nephrectomies (n = 40), cystorrhaphy with suture (n = 20) and uterine-vesical anastomosis (n = 20). Times needed to perform the exercises and the principal errors perceived during the performance of each one of the tasks were recorded. The tasks, of growing complexity, were performed with the instruments described in increasingly less time and with less difficulty. An accessory trocar of 3.5 mm was required to perform the in vivo sutures. CONCLUSIONS The KeyPort approach has potential application in different urological applications. Standardized training allows the acquirement of skills and makes the successful implementation possible of a laparoendoscopic surgery program in humans.

Estado actual de la cirugia transumbilical por puerto unico en urologia: retos y aplicaciones

CONTEXT Laparoscopic surgery in urology is considered to be an important advance, although it is not exempt from some morbidity associated to the use of multiple trocars and specifically to the extraction of the specimen. In order to decrease this morbidity and improve esthetics, other techniques are being developed, such as natural orifice transluminal endoscopic surgery (NOTES) and laparoendoscopic single-site surgery (LESS). It is aimed to review the current status of laparoendoscopic single site surgery in urology. ACQUISITION OF EVIDENCE A nonsystematic review has been carried out by means of the bibliographic search using the terms LESS and Urology from 2007 to 2012. The current LESS experience in urology is described, and its principal indications and the different single site devices and instruments available on the market are described. SYNTHESIS OF EVIDENCE LESS surgery arose as one more step in the constant evolution of minimally invasive surgery in an attempt to improve esthetics, reduce surgical trauma and decrease pain and the post-operative complications associated to the conventional laparoscopy with multiple trocars. Since it was first described in 2007, the experience has been increasing exponentially and the LESS technique, whether assisted or not by robot, is becoming consolidated for a large spectrum of urological indications (both in oncological and reconstructive surgery) on a much greater scale than the NOTES technique. Even though most of the existing data are not randomized and very rarely comparative, with the selection bias that this represents, it seems clear that the esthetic benefit and analgesic control associated to the LESS surgery is real and reproducible. The complications associated to it are greater in cases of major oncology surgery and are due more to the technique itself then to the approach. CONCLUSIONS Although the real benefit of the LESS surgery in urology cannot be appropriately quantified, the cosmetic improvement, less pain and greater patient satisfaction with their wound are clear. Appropriate training in this type of procedures in centers having large volumes and the continuous technical improvements in the instrumental development by the biomedical industry has resulted in the fact that the transumbilical LESS technique in urology has been born to stay.

Estudio comparativo entre cirugía retrógrada intrarrenal y micro-nefrolitotomía percutánea en el tratamiento de la litiasis renal de tamaño intermedio

OBJECTIVE Retrograde intrarenal surgery (RIRS) has proven efficacy with minimal morbidity in the treatment of intermediate-sized kidney stones. The aim of this study was to examine the feasibility of micropercutaneous nephrolithotomy (microperc) for this indication and evaluate its results compared with those of RIRS. MATERIAL AND METHODS From September to December 2013, we performed a comparative prospective study between RIRS and microperc, with 20 consecutive patients with intermediate-sized (1-3cm) kidney stones. We employed a flexible dual-channel ureteroscope (Cobra, Richard Wolf GmbH) and a Microperc 4.85/8 Fr (with the patient supine) with flexible fiberoptics (0.9mm, 120° and 10,000 pixels) (PolyDiagnost GmbH). The study variables were demographic data, stone characteristics, percentage of stone elimination, complications (Clavien-Dindo), surgical time, hospital stay and need for auxiliary procedures. RESULTS The patients underwent RIRS (n=12) or microperc (n=8). There were no differences in the demographics or stone characteristics between the 2 groups. The percentage of stone elimination with RIRS and microperc was 91.7% and 87.5% (P=1), respectively. One of the patients who underwent RIRS (8.3%) experienced postoperative fever; one of the patients who underwent microperc (12.5%) experienced postoperative colic pain (both cases were classified as Clavien I). The operative times were similar: 120min (111.2-148.7) and 120 (88.7-167.5) min for RIRS and microperc (P=.8), respectively. None of the patients required a blood transfusion. The hospital stays were also equivalent: 1 day (1-2) and 1.5 days (1-3.5) for RIRS and microperc (P=.33), respectively. Two patients treated with microperc (25%) required auxiliary procedures (simultaneous RIRS and flexible nephroscopy after percutaneous trajectory dilation to treat, in both cases, a significant fragment that had migrated to an inaccessible calyx), and 1 patient in the RIRS group (8.3%) required percutaneous nephrolithotomy due to unfavorable infundibular-calyceal anatomy (P=.54). CONCLUSIONS Microperc is a minimally invasive method that is emerging as an effective and safe treatment for intermediate-sized kidney stones. Studies are needed to better evaluate its cost-effectiveness, the need for complementary treatments and its possible complementarity with RIRS when working with patients in the supine position.

Umbilical laparoendoscopic urological surgery with a novel reusable device

Abstract Objective.The aims of this study were to present cumulative experience with umbilical laparoendoscopic urological surgery using a reusable device and to evaluate outcomes and complications in the first 100 patients. Material and methods. Patients undergoing umbilical surgery with the KeyPort system and DuoRotate instruments (Richard Wolf, Knittlingen, Germany) were evaluated prospectively. Demographic, intraoperative and postoperative data were assessed. Results.Between October 2011 and July 2012, 79 pelvic (66 radical prostatectomy, 10 radical cystectomy, one diverticulectomy, one bilateral orchiectomy, one ureter reimplantation) and 21 renal (seven radical nephrectomy, six partial nephrectomy, five nephroureterectomy, two pyeloplasty, one pyelolithotomy) surgeries were performed through the umbilicus using this platform. Follow-up was 56.7 ± 12.6 weeks (mean ± SD). Mean age was 64.3 ± 10.3 years, body mass index 29 ± 4.6 kg/m2, operative time 232 ± 106 min and estimated blood loss 260 ± 95 ml. Conversion to standard multiport laparoscopy was not necessary. An accessory port was used in 87 cases to facilitate suturing and conduct drainage extraction. Postoperative complications occurred in 24 cases (six Clavien grade I, 12 grade II, one grade IIIa, two grade IIIb, two grade IVa, one grade IVb). Mean hospital stay was 4.2 ± 4 days. Total transfusion rate was 10%. Mean visual analogue pain scale at day 2 was 2.1 ± 1.3 (0–10). Visual analogue wound satisfaction scale at month 1 was 9.2 ± 0.6 (0–10). No cancer-related events occurred during follow-up. Late complications (4%) were not related to the surgical approach. Conclusions.Umbilical KeyPort surgery is technically feasible for a great variety of procedures, both ablative and reconstructive. This access offers adequate surgical outcomes, scarce postoperative pain and security for the patient in the short term. Its reusable nature implies a noticeable economic advantage.

Pielolitectomía por puerto único umbilical sobre riñón en herradura: una nueva indicación

INTRODUCTION Laparoscopic surgery through a single port is an evolution of laparoscopic surgery, possible after recent technological development of new access systems. It is an established minimally invasive technique, although its indications in the field of Urology are currently under development. MATERIAL AND METHODS We present the first case of incision-less pyelolithectomy, performed through a single-port placed in the umbilicus, performed in a 47 years-old male patient (38.2 BMI) with solitary 4 cm diameter lithiasis in a horseshoe kidney. An umbilical 2.5 cm incision was used for the introduction of a prototype of the reusable Richard Wolf single-port system, without any ancillary elements. RESULTS After placement of left double-J stent proximal left ureter and renal pelvis, pyelolithectomy and pyelorraphy were performed with DuoRotate-Instruments© (Richard Wolf). Water-tightness was demostrated with methylene blue intravesical instillation and no drain was placed. The procedure lasted for 280 min and bleeding was 30 cc. The patient was discharged 24 hours later without pain. CONCLUSION Incision-less pyelolithectomy is a feasible and resolutive option to treat pelvic lithiasis. It can be considered the most beneficial option in aesthetical terms in experienced centers, especially in peculiar cases like horseshoe kidney.

Nefrectomía parcial laparoscópica

OBJECTIVES To analyze the surgical and oncologic outcome of prospective experience with laparoscopic partial nephrectomy. We describe the surgical technique and mid term oncological results achieved. MATERIAL AND METHODS 60 patients were operated with this technique between June 2005 and June 2009. The mean age of patients was 58.9 [38-77] years, being 40 (66.7%) males and 20 (33.3%) women. The average BMI was 26.8 [18-40]. Laterality was 28 (46.7%) tumors rights and 32 (53.3%) left, being located in the upper pole in 14 (23.3%) patients, in the middle third in 13 (21.7%) in the lower pole in 22 (36.7%) and hiliar region in 11 (18.3%). In 23 cases (38.3%) tumors were located in the anterior valve, in 24 (40%) in posterior valve, in 10 (16.7%) at the outer edge and 3 (5%) at the inner edge. The average size tumor on CT was 3.3 [1-6.4] cm and in the surgical specimen 3.1 [1.2-7] cm. RESULTS The mean operative time was 107.17 [50-185] min, with a warm ischemia time of 33 [0-70] min. In 56 cases (93.3%) had a single artery and 4 (6.7%) cases had 2 arteries. The artery was clamped alone in 15 patients (25%), artery and vein in 44 (73.3%) and no clamping was performed in 1 (1.7%). We repaired the urinary tract in 32 patients (53.3%), leaving ureteral catheter in all patients. 20% of patients (12) required transfusion. Intraoperative complications occurred in 5 patients (8.7%). These were: 1 splenic injury requiring splenectomy (1.7%), 1 tear in the vena cava, sutured laparoscopically (1.7%) and 3 cases of bleeding due to bulldog malfunction (5%). Postoperative complications occurred in 11 patients (18.7%) and these were: 1 wall hematoma that required reoperation (1.7%), 1 urinary fistula ending in renal atrophy and subsequent nephrectomy (1.7%), 3 intracavitary hematomas hich resolved conservatively (5%), 1 arteriovenous fistula that needed embolization (1.7%), 1 urinoma that was resolved with percutaneous drainage (1.7%) and 3 cases of postoperative fever (5%). Margins were positive in 1 patient (1.7%). In 49 cases (81.7%) histology was renal cell carcinoma, in 8 (13.3%) oncocytoma, in 2 (3.3%) angiomyolipoma and 1 (1.7%) metastasis. The average stay was 5 [3-29] days. Median follow up was 31 [12-61] months. There was a local recurrence at 16 months (hiliar primary tumor 2.5 cm) and an ipsilateral adrenal metastasis at 34 months (primary tumor 5.6 cm in left lower pole). CONCLUSIONS In this series of laparoscopic partial nephrectomy low rate of complications, good oncologic results and low recurrence rate in the short term are shown. More patients and further monitoring is required to strengthen the functional and oncological outcomes of this surgical technique.

Reimplantación ureteral laparoendoscópica por puerto único transumbilical

OBJECTIVE To analyze the outcomes of umbilical laparoendoscopic single-site (LESS) ureteral reimplantation using a reusable single-port platform. MATERIAL AND METHOD The casuistic of LESS ureteral reimplantation in 5 patients is presented. The surgical technique using KeyPort system (reusable umbilical single-site platform) is described. Dissection, suctioning and suturing by minilaparoscopy through 3.5mm accessory port in the iliac fossa are performed. Operative and postoperative outcomes are presented. The median follow-up at time of analysis was 11 ± 14 months. RESULTS The median age of patients was a 49 ± 34 year; male-female ratio was 1:1.15. Left surgery was carried out in all cases. In 4 patients, the etiology was secondary to stenosis (3 iatrogenic and 1 pelvic endometriosis). In the remaining case, the procedure was performed after excision of a symptomatic adult ureterocele. In all cases, bladder catheter and double-J ureteral catheter were inserted for 7 ± 3 and 30 ± 15 days and then removed. No conversion to convectional laparoscopic or open surgery occurred. The surgery time was 145 ± 60 min, and intraoperative bleeding was 100 ± 75 cc. Neither transfusion nor high analgesia was necessary. No postoperative complications, minor or major, have been reported. Hospital stay was 2 ± 0.5 days. In any patient, restenosis or worsening of renal function occurred. CONCLUSIONS In experimented centers, transumbilical laparoendoscopic single-site ureteroneocystostomy is a safe alternative with comparable results to conventional laparoscopy and an excellent cosmetic result at low cost thanks to device reuse.