Feasibility and Preliminary Clinical Outcomes of Robotic Laparoendoscopic Single-Site (R-LESS) Pyeloplasty Using a New Single-Port Platform

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1 EUROPEAN UROLOGY 62 (2012) available at journal homepage: Case Series of the Month Feasibility and Preliminary Clinical Outcomes of Robotic Laparoendoscopic Single-Site (R-LESS) Pyeloplasty Using a New Single-Port Platform Andrea Cestari *, Nicolò Maria Buffi, Giuliana Lista, Giovanni Lughezzani, Alessandro Larcher, Massimo Lazzeri, Mattia Sangalli, Patrizio Rigatti, Giorgio Guazzoni Department of Urology, Vita-Salute University, San Raffaele-Turro Hospital, Milan, Italy Article info Article history: Accepted March 20, 2012 Published online ahead of print on March 28, 2012 Keywords: Robotic surgery Single site platform UPJ obstruction Renal diseases Abstract This study tested the technical feasibility and short-term perioperative outcomes of the novel da Vinci Single-Site Instrumentation platform for the treatment of upper ureteropelvic junction obstruction (UPJO) in a selected group of patients. Nine patients underwent robotic laparoendoscopic single-site (R-LESS) pyeloplasty using a new single-site platform for UPJO at our department of urology. All the procedures were completed without the need for traditional robotic surgery or laparoscopic/open conversion, although in one patient with congenital hepatomegaly it was necessary to use an auxiliary 3-mm trocar to retract the liver properly and expose the surgical field. Mean operative time was 166 min, and no intraoperative complications were recorded. The indwelling catheter was removed on postoperative day 2 in five patients and on postoperative day 3 in four patients. Patients were discharged the day after drain removal. One patient experienced transient hyperpyrexia, treated with antibiotics. No other complications were observed. All patients had the DJ stent removed 4 wk after surgery, following a negative urine culture and abdominal ultrasound evaluation. The five patients who reached a 3-mo follow-up had a clinical resolution of preoperative symptoms and hydronephrosis at the abdominal ultrasound. The same results were maintained in the two patients with 6-mo follow-up evaluations. In selected patients, R-LESS pyeloplasty using the new single-port platform appears to be a technically feasible and reproducible surgical procedure for the minimally invasive treatment of UPJO. Prolonged follow-up and larger series are required to confirm its potential role as a valid alternative to standard robotic pyeloplasty. # 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved. * Corresponding author. Department of Urology, Vita-Salute University, San Raffaele-Turro Hospital, Via Stamira D Ancona 20, Milan, Italy. Tel address: a_cestari@yahoo.it (A. Cestari). 1. Case report Laparoendoscopic single-site surgery (LESS) aims to reduce the limited invasiveness of conventional laparoscopy even further and to offer not only a better cosmetic result (incision hidden by the umbilical scar) but also potentially to reduce postoperative pain and offer a quicker convalescence [1]. Nevertheless, LESS remains a challenging surgical technique mainly due to the lack of triangulation among the surgical instruments. Proper laparoscopic suturing techniques and great surgical skills are required for procedures such as pyeloplasty, and proper suturing is /$ see back matter # 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved. doi: /j.eururo

2 176 EUROPEAN UROLOGY 62 (2012) [(Fig._1)TD$FIG] mandatory to adequately repair the stenotic ureteropelvic junction (UPJ). Recently, the da Vinci single-site surgery technique was introduced into clinical practice to perform cholecystectomy procedures robotically in a LESS surgery scenario, with encouraging preliminary results [2,3]. However, cholecystectomy in general is a much easier procedure. The aim of this study was to test the technical feasibility and reproducibility and to evaluate the perioperative shortterm outcomes of pyeloplasty performed by using the novel da Vinci Single-Site Instrumentation platform in a selected group of patients. Nine patients were selected for robotic LESS pyeloplasty for symptomatic UPJ obstruction (UPJO) using the novel da Vinci single-site platform at our university department of urology tertiary care hospital between July 2011 and December Patients were selected according to the results of imaging techniques, mercaptoacetyltriglycine-3 diuretic renal scans showing evident obstruction not solved following furosemide injection (t 1/2 >20 min), and the presence of symptoms (eg, recurrent flank pain, fever, and recurrent upper urinary tract episodes). Exclusion criteria for these preliminary series were a body mass index (BMI) >30 kg/m 2, previous abdominal and renal surgery, concomitant renal stones, an extremely large renal pelvis (ie, pelvis diameter >6cm), pelvickidney, and horseshoe kidney. Table 1 lists the demographics and preoperative characteristics of the patients. Patients signed an informed consent before surgery and were made aware of the possibility that the surgery might be converted into a traditional robotic pyeloplasty or open surgery. The new da Vinci single-site robotic surgery platform is a semirigid robotic operative system designed to work with the Intuitive da Vinci Si Surgical System (Intuitive Surgical, Sunnyvale, CA, USA). The system, which incorporates a multichannel single port that accommodates two curved robotic cannulas, allows for the passage of interchangeable semirigid instruments that cross each other within the trocar so that the right-entering instrument becomes the left-sided operative instrument in the abdominal cavity and vice versa. The master-slave software of the da Vinci platform automatically exchanges the master-slave controls allowing the surgeon at the console to control the tip oftheinstrumentwithhisrighthandattherightsideofthe Table 1 Demographics and preoperative data of the series of R-LESS pyeloplasty using the new single-port platform Patients, n 9 Age, yr, median (range) 32 (19 55) Side (right/left) 8/1 BMI (kg/m 2 ), median (range) 22.5 ( ) Symptoms Flank pain: 9 patients Urinary tract infections: 1 patient Preoperative renal scan t 1/2 28 (21 32) post-lasix, min, median (range) BMI = body mass index. Fig. 1 Scheme of the da Vinci single-site platform. surgical field and the opposite for the left. Unfortunately, the surgical instruments do not have the wrist at the tip like conventional robotic da Vinci instruments do. In addition to the robot-controlled instruments and optic (a 308 scope down oriented), the specifically designed port allows for the access of additional one or two conventional laparoscopic entrances for the assistant (Fig. 1). At the present time, this technology is only approved in the United States for cholecystectomy. Patients were positioned in a 758 flank position with the bed flexed (308) to elevate the surgical area (Fig. 2a). Thesurgicalfieldwaspreparedtohavefullaccesstothe target abdominal area and the penis in males and vagina in females, adequately providing access to the external urinary meatus to perform the flexible cystoscopy for DJ stent positioning. A 2- to 2.5-cm intraumbilical skin incision was performed with a dissection of the musculofascial planes to reach the peritoneal cavity. The da Vinci single-site port was then inserted and pneumoperitoneum induced (Fig. 2b). The transperitoneal pyeloplasty surgical technique was carried out as previously described for standard robotic pyeloplasty at our institution [4]. To ease the plasty reconfiguration, a braided 3-0 monodermal suture was

3 [(Fig._2)TD$FIG] EUROPEAN UROLOGY 62 (2012) [(Fig._3)TD$FIG] Fig. 2 (a) Patient positioning; (b) single-site port inserted in the umbilical scar. Fig. 3 Single-site da Vinci platform docked to the patient. used (Quill, Angiotech Pharmaceuticals, USA). The needles were inserted and removed under direct vision through the assistant port using a laparoscopic needle driver. Once the posterior plate of the anastomosis was completed, a DJ stent was inserted retrogradely using a flexible cystoscope in order not to modify the patient s position and the undockingredocking of the robotic arm system to ease the procedure and save time. The technique included retrograde guidewire insertion through the flexible cystoscope into the renal pelvis and subsequently DJ positioning. Once the DJ stent was correctly placed, a Foley catheter was inserted in the urinary bladder, the anterior aspect of the anastomosis was completed, and the remaining open pelvis was closed in a similar fashion when necessary (Figs. 3 5). Patients were mobilised and allowed to resume an oral diet from postoperative day 1. Based on clinical evaluation, postoperative management included catheter removal from postoperative day 2. The drain was removed h after surgery if the output was inferior to 50 ml, and the patient was subsequently discharged from the hospital. The DJ stent was removed by means of cystoscopy in an office-based setting 4 wk after surgery, following a negative urine culture and ultrasound evaluation. The follow-up protocol included a clinical and ultrasound evaluation 3 mo after surgery and clinical, ultrasound, and renal scan evaluation at 6-mo follow-up. Complications were reported according to the Clavien-Dindo classification system [5]. Table 2 reports the perioperative outcomes of the series. [(Fig._4)TD$FIG] Fig. 4 Intraoperative dissection of the hydronephrotic renal pelvis.

4 178 [(Fig._5)TD$FIG] EUROPEAN UROLOGY 62 (2012) It was necessary to use an auxiliary 3-mm trocar to retract the liver properly and expose the surgical field in one patient with congenital hepatomegaly. Mean operative time was 169 min (range: min). No intraoperative complications were recorded, and blood loss was minor. The indwelling catheter was removed on a clinical basis on postoperative day 2 in five patients and on postoperative day 3 in four patients. Patients were discharged the day after drain removal. One patient experienced transient hyperpyrexia and was treated with antibiotics (Clavien- Dindo grade 2). No other complications were observed. All patients had the DJ stent removed 4 wk after surgery following a negative urine culture and abdominal ultrasound evaluation. The five patients who reached a 3-mo follow-up showed resolution of preoperative symptoms and resolution of hydronephrosis at the ultrasound evaluation. The same results and absence of urinary obstruction at the renal scan (t 1/2 20 min) was maintained in the two patients who reached the 6-mo follow-up (8 and 11 min, respectively). 2. Discussion Fig. 5 Aesthetic results (a) at the end of the procedure; (b) 1 mo after surgery. Each procedure was completed as programmed with the new robotic platform without converting the procedure into classic robotic surgery or open surgery, and the DJ stent was positioned using a cystoscope during the procedure without any difficulties. Table 2 Perioperative outcomes of the series of patients submitted to R-LESS pyeloplasty using the new single-port platform Surgical time, min, median (range) 160 ( ) Foley catheter removal, d, median (range) 2 (2 3) Drain removal, d, median (range) 4 (3 4) Hospital stay, d, median (range) 4 (3 5) Crossing vessels, no. 3 Intraoperative complications 0 Postoperative complications 1 (hyperpyrexia) Mean follow-up, mo, median (range) 4 (2 6) In the last decade minimally invasive surgery has expanded its role in the management of UPJO [6]. LESSpyeloplasty has been reported as a feasible minimally invasive surgical option for UPJ repair [7], hiding the surgical incision inside the umbilical scar while permitting a dismembered technique. Due to the lack of proper intra-abdominal instruments triangulation, LESS suturing appears to be extremely demanding, even for a skilled laparoscopist [1]. LESS suturing is considered the most challenging step of LESS pyeloplasty [8] with an increased risk of urinary fistula formation and a subsequent increased risk of UPJO recurrence. Best et al. [9] reported a urinary anastomotic leak in 11% of patients and the frequent need to use an auxiliary 3- or 5-mm port to achieve proper instrument triangulation for correct suturing. More recently, the advent of the da Vinci platform eased the suturing phase, the more complex and important step of the pyeloplasty [10]. Kaouk et al. [1] reported the feasibility of da Vinci single-port pyeloplasty on two patients using 5-mm surgical instruments and a gel-port platform for the access. In their preliminary experience they reported large skin incisions (up to 5 cm) and the problem of external conflict of the robotic arms during the procedures. More recently, Olweny et al. [11] reported the feasibility of single site-robotic pyeloplasty using 5-mm in diameter robotic instrumentation: The skin incision in their series was cm, and frequently a transposition of robotic instruments during dissection and sewing was required. For all right-side procedures, an auxiliary 3-mm port was required to retract the liver. In our experience the skin incision required to insert the single-site port properly was limited to cm, offering the opportunity for an optimal cosmetic result. We never experienced external collisions between the robotic arms in any of the procedures, and only in one case was it necessary

5 EUROPEAN UROLOGY 62 (2012) to add a 3-mm port to retract the liver in a patient with congenital hepatomegaly. The da Vinci single-site technology was specifically developed to overcome some of the disadvantages and problems of LESS surgery. One of the greatest advantages of this system is the restoration of intra-abdominal triangulations of the instruments by the use of semirigid tools passing through rigid curved cannulas. This creates instrument separation and sufficient triangulation at the working edges with adequate rigidity of the instruments themselves. The space between the robotic arms is sufficient for the assistant to do his or her job, albeit with some movement limitations. The use of an HD 3D camera allows for an optimal visualization of the surgical field with a stable image. The 308 laparoscope is also necessary to minimise the internal conflicts between the surgical instruments and the optical system. Current and potential limitations of R-LESS pyeloplasty using the new single-port platform are mainly related to the limited availability of surgical instruments including the lack of monopolar curved scissors and bipolar forceps. Most importantly, the lack of EndoWrist movement at the tip of the instruments requires the surgeon to have excellent standard laparoscopic suturing skills. Due to these restrictions, we limit the indications for R-LESS pyeloplasty using the new single-port platform to patients with a BMI <30 kg/m 2 and without previous major abdominal or renal surgery and/or previous renal inflammatory diseases or renal stones. Although the instrument triangulation offered by the da Vinci Single-Site Instrumentation has always been adequate for both the dissection and reconstructive phases, we prefer to insert the DJ stent retrogradely, via a flexible cystoscope, to simplify this step of the procedure. We are the first to report the successful use of da Vinci single-site technology in urology. We successfully performed R-LESS pyeloplasty using the new single-port platform on nine patients including three cases where aberrant crossing vessels were found and de-crossed. We demonstrated the feasibility and reproducibility of the technique along with patient satisfaction; they experienced a short postoperative stay and convalescence and had an excellent aesthetic result. However, clinical benefits for the patient versus standard laparoscopic or robotic pyeloplasty remain unproven. The limits of this study mainly rely on the limited casuistic and short follow-up, although the preliminary results appear promising. Larger series and prospective studies comparing R-LESS pyeloplasty using the new singleport platform with standard robotic pyeloplasty are necessary to properly define the role of this innovative surgical technique. Conflicts of interest: The authors have nothing to disclose. EU-ACME question Please visit to answer the following EU-ACME question online (the EU- ACME credits will be attributed automatically). Question: Which of the following is not a characteristic of the novel da Vinci single-site platform? A. Three-dimensional image B. Restoration of intracorporeal instruments triangulation C. EndoWrist movement at the tip of the instruments D. Limited working space for the assistant at the table References [1] Kaouk JH, Autorino R, Kim FJ, et al. Laparoendoscopic single-site surgery in urology: worldwide multi-institutional analysis of 1076 cases. Eur Urol 2011;60: [2] Kroh M, El-Hayek K, Rosenblatt S, et al. First human surgery with a novel single-port robotic system: cholecystectomy using the da Vinci Single-Site platform. Surg Endosc 2011;25: [3] Wren SM, Curet MJ. Single-port robotic cholecystectomy results from a first human use clinical study of the new da Vinci single-site surgical platform. Arch Surg 2011;146: [4] Cestari A, Buffi NM, Lista G, et al. Retroperitoneal and transperitoneal robot-assisted pyeloplasty in adults: techniques and results. Eur Urol 2010;58: [5] Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004;240: [6] Braga LHP, Pace K, DeMaria J, Lorenzo JA. Systematic review and meta-analysis of robotic-assisted versus conventional laparoscopic pyeloplasty for patients with ureteropelvic junction obstruction: effect on operative time, length of hospital stay, postoperative complications, and success rate. Eur Urol 2009;56: [7] Tugcu V, Sonmezay E, Llbey YO, Polat H, Tasci AI. Transperitoneal laparoendoscopic single-site pyeloplasty: initial experiences. J Urol 2010;24: [8] Gill IS, Advincula AP, Aron M, et al. Consensus statement of the consortium for laparoendoscopic single-site surgery. 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