EURURO-5576; No. of Pages 6 EUROPEAN UROLOGY XXX (2014) XXX–XXX
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Surgery in Motion
Robot-assisted, Single-site, Dismembered Pyeloplasty for Ureteropelvic Junction Obstruction with the New da Vinci Platform: A Stage 2a Study Nicolo` Maria Buffi a,*, Giovanni Lughezzani a, Nicola Fossati a, Massimo Lazzeri a, Giorgio Guazzoni a, Giuliana Lista a, Alessandro Larcher a, Alberto Abrate a, Cristian Fiori b, Andrea Cestari c, Francesco Porpiglia b a
Department of Urology, San Raffaele Turro Hospital, Milan, Italy;
c
Department of Urology, Istituto Auxologico Italiano, Milan, Italy
b
Department of Urology, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy;
Article info
Abstract
Article history: Accepted March 3, 2014 Published online ahead of print on March 13, 2014
Background: Laparoendoscopic single-site surgery (LESS) has gained popularity in urology over the last few years. Objective: To report a stage 2a study of robot-assisted single-site (R-LESS) pyeloplasty for ureteropelvic junction obstruction (UPJO). Design, setting, and participants: This study is an investigative pilot study of 30 consecutive cases of R-LESS pyeloplasty performed at two participating institutions between July 2011 and September 2013. Surgical procedure: Dismembered R-LESS pyeloplasty was performed at two surgical centers. Measurements: Feasibility (conversion rate), safety (complication rate and Clavien-Dindo classification), efficacy (clinical outcome) of the procedure were assessed. Results and limitations: The median patient age was 37 yr (range: 19–65 yr) and median body mass index was 23 kg/m2 (range: 19–29 kg/m2). The median operative time was 160 min (range: 101–300 min), the median postoperative stay was 5 d (range: 3–13 d), and the median time to catheter removal was 3 d (range: 2–10). Two cases required conversion, the first one to standard laparoscopic technique and the second one to standard robotic technique. No intraoperative complications were reported. In three cases, an additional 5-mm trocar was needed. The postoperative complications rate was 26% (n = 8). Most of them were grade 1 complications (n = 4; 13%), followed by grade 2 (n = 3; 10%) and grade 3 (n = 1; 3.3%) complications, according to the Clavien-Dindo classification. One patient needed a surgical reintervention with standard robotic technique 3 d after surgery for urinary leakage. The overall success rate, considered as the resolution of symptoms and the absence of functional impairment at postoperative imaging, was 93.3% (n = 28) at a median follow-up of 13 mo (range: 3–21 mo). The main limitations of this study are the limited number of patients included and the short-term follow-up. Conclusions: Single-site robotic pyeloplasty is a feasible technique in selected patients, with good cosmetic results and excellent short-term clinical outcomes. Prospective studies are needed to further assess its role for the treatment of UPJO. Patient summary: Single-site robot-assisted pyeloplasty is a feasible technique with good cosmetic results and excellent short-term clinical outcomes. # 2014 Published by Elsevier B.V. on behalf of European Association of Urology.
Keywords: Robotic surgery Single site Pyeloplasty Ureteropelvic junction obstruction Please visit www.europeanurology.com and www.urosource.com to view the accompanying video.
* Corresponding author. Department of Urology, San Raffaele Turro Hospital, Vita-Salute San Raffaele University, Via Stamira D’Ancona, 20, 20127 Milan, Italy. Tel. +39 02 2643 7286; Fax: +39 02 2643 7298. E-mail address: buffi[email protected] (N.M. Buffi). http://dx.doi.org/10.1016/j.eururo.2014.03.001 0302-2838/# 2014 Published by Elsevier B.V. on behalf of European Association of Urology.
Please cite this article in press as: Buffi NM, et al. Robot-assisted, Single-site, Dismembered Pyeloplasty for Ureteropelvic Junction Obstruction with the New da Vinci Platform: A Stage 2a Study. Eur Urol (2014), http://dx.doi.org/10.1016/j.eururo.2014.03.001
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1.
Introduction
The follow-up program included an abdominal ultrasound, urinalysis, and a urine culture after 1 mo, as well as a CT urography and MAG-3
Laparoendoscopic single-site surgery (LESS) has been proposed as an evolutionary step beyond standard laparoscopy and, since its introduction, has been increasingly adopted by urologists worldwide [1,2]. The adoption of this technique was mainly driven by the hypothesis that the minimization of the skin incision to gain access to the abdominal or pelvic cavities may benefit patients in terms of port-related complications, recovery time, postoperative pain, and cosmetic results [3,4]. However, this technique remains highly challenging, even for expert laparoscopic surgeons. Although application of the da Vinci robotic single-port platform (Intuitive Surgical Inc, Sunnyvale, CA, USA) combined with 8-mm standard instruments has the potential to overcome some of these challenges, such as the steep learning curve and difficult intracorporeal suturing, reports to date reveal only a marginal benefit of this approach, largely due to internal and external robotic-arm clashing [5]. More recently, LESS has been merged with robot-assisted surgery (R-LESS) [6] using a new, robotic, single-site platform with 5-mm flexible instruments. Evidence supporting R-LESS pyeloplasty has been limited to a single small case series. Further multicentric studies are required to gain more evidence regarding the effectiveness and feasibility of this technique. We present the first, prospective, multicenter study of R-LESS pyeloplasty with the new da Vinci single-site platform developed within stringent criteria of clinical surgical research.
diuretic renal scan after 6 mo. Ultrasound was repeated annually and an evaluation of symptom relief at each follow-up visit was done. Follow-up visits were done at 1, 3, 6, and 12 mo, and then annually. Criteria for success were clinical resolution of symptoms, no radiologic evidence of obstruction at CT urography, and no functional evidence of obstruction at MAG-3 renal scan.
2.1.
Surgical technique
The surgeons were trained on dry and wet laboratories before starting the first case and had the opportunity to discuss the surgical procedure together. Robotic, single-site pyeloplasty was performed using the new da Vinci single-site robotic surgery platform according to the AndersonHynes technique. In all patients, a double-J (DJ) ureteral stent was positioned retrograde. The stent was removed after approximately 30 d. The new da Vinci single-site robotic surgery platform is a semirigid, robotic operative system designed to work with the da Vinci Si Surgical System (Intuitive Surgical). The system incorporates a multichannel single port that accommodates two curved, robotic cannulas and allows for the passage of interchangeable semirigid instruments that cross each other within the trocar. The instrument entering on the right side 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 of the instrument with the right hand at the right side of the 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 robotcontrolled instruments and optic (a 308 scope down oriented), the specifically designed port allows for the access of an additional one or two conventional laparoscopic entrances for the assistant. The robot-assisted, single-site surgical technique was performed
2.
Materials and methods
using the previously described procedure [12] with a transperitoneal approach [13]. Patients were positioned in a 758 flank position with the
A stage 2a development (ie, investigative, pilot) study was conducted [7].
bed flexed (308) to elevate the surgical area. A double-sterile field was
Between July 2011 and December 2013, we enrolled 30 patients who
prepared to have full access to the target abdominal area, the penis in
underwent R-LESS pyeloplasty for ureteropelvic junction obstruction
males and the vagina in females, adequately providing access to the
(UPJO). Patients were treated at two high-volume laparoscopic and
external urinary meatus to perform the flexible cystoscopy for DJ stent
robotic surgery centers (center 1: San Raffaele Turro Hospital, Milan,
positioning.
Italy; center 2: San Luigi Gonzaga Hospital, Orbassano, Turin, Italy). Indications to surgery were based on the results of imaging
A 2- to 2.5-cm intraumbilical skin incision was performed with a dissection of the musculofascial planes to reach the peritoneal cavity;
techniques, mercaptoacetyltriglycine-3 (MAG-3) diuretic renal scans
2-0 polyglactin holding stitches are placed alongside the programmed,
showing evident obstruction not solved following furosemide injection
vertical fascial incision to mark the anterior fascia, the underlying
(half-life >20 min), and the presence of symptoms (eg, recurrent flank
transversalis fascia, and peritoneum. These are incised, and the
pain, fever, and recurrent upper urinary tract episodes). Exclusion
peritoneal cavity is entered. The da Vinci single-site ports are then
criteria were a body mass index (BMI) >30 kg/m2, previous abdominal
placed and pneumoperitoneum induced through a GelPort (Applied
and renal surgery, an extremely large renal pelvis (ie, pelvis diameter
Medical Resources Corp, Rancho Santa Margarita, CA, USA) inserted into
>6 cm), pelvic kidney, and horseshoe kidney.
the umbilical incision. Difficulties may occur in the introduction of the
Patients signed an informed consent before surgery and were
GelPort into the 2-cm umbilical incision, but could be overcome using
especially made aware of the possibility that the surgery could be
the right method of folding the GelPort and using a Satinsky clamp like a
converted into a traditional robotic or laparoscopic procedure.
shoehorn. The GelPort is then twisted toward the target to align the
The end points of this study were (1) feasibility, expressed as
robotic optic arm. In the docking of the da Vinci system, the camera arm
conversion rate; (2) safety, estimated by complication rate according to
has to remain in line with the target, perpendicular to the GelPort, to
Clavien-Dindo classification [8]; and (3) efficacy, consisting of the
show the insertion of first the second robotic arm, and then the first arm.
functional and symptomatologic success of surgical treatment evaluated
To minimize conflicts between the arms, the first two joints of each arm
with computed tomography (CT) urography and MAG-3 diuretic renal
have to be aligned. Once the system is docked, all arms should be lifted to
scan, visual analog scale (VAS) of pain [9], and good cosmetic results
gain more space. Carbon dioxide is inserted through the camera trocar;
evaluated using a patient scar-assessment scale (PSAS), a 6-item self-
meanwhile, the assistant controls two other, different trocars.
report scale in which items are scored on a numeric rating of 0–10 [10]
The right side of the parietal peritoneum, overlying Gerota’s fascia, is
and a VAS for cosmesis [11]. The latter is a 10-point scale evaluating the
incised and the target structures (the ureter, the dilated renal pelvis, and,
subjective aesthetic judgment of the scar. A higher score means a good
eventually, the aberrant crossing vessels) are exposed. On the left side,
subjective judgment.
typically the white line of Toldt is incised and the left colon is mobilized
Please cite this article in press as: Buffi NM, et al. Robot-assisted, Single-site, Dismembered Pyeloplasty for Ureteropelvic Junction Obstruction with the New da Vinci Platform: A Stage 2a Study. Eur Urol (2014), http://dx.doi.org/10.1016/j.eururo.2014.03.001
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EUROPEAN UROLOGY XXX (2014) XXX–XXX
medially to expose Gerota’s fascia, which is incised, isolating the target structures. Robotic bipolar forceps and monopolar scissors are used to dissect the proximal ureter and the dilated renal pelvis. The stenotic ureteropelvic
Table 1 – Descriptive characteristics of 30 patients affected by ureteropelvic junction obstruction treated with robot-assisted single-site pyleoplasty between July 2011 and December 2013 Preoperative variables
Values
junction was excised; the ureter was then spatulated longitudinally and the pyeloplasty performed according to the Anderson-Hynes technique. The posterior aspect of the anastomosis was performed with a running 5-0 Vicryl suture (Ethicon Endo-Surgery Inc, Cincinnati, OH, USA) RB2 needle. 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 retrograde using a flexible cystoscope to ease the procedure and save time by not modifying the patient’s position and undocking and redocking the robotic arm system. 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 and the anterior aspect of the anastomosis was completed. At the end of the procedure, once complete hemostasis was achieved, a suction drain was left in place. In the case of a crossing vessel, a dismembered pyeloplasty with transposition of the reanastomosed ureter ventral to the vessels was performed. Stone removal was feasible in all cases with a flexible cystoscope though the 10-mm port. Stones are removed using a basket and put into a retrieval bag, which is removed at the end of the surgical procedure.
3.
Results
Demographic characteristics and preoperative data of the population are showed in Table 1. Thirty patients underwent single-site robotic pyeloplasty, 18 were treated in center 1 and 12 in center 2. Median patient age was 37 yr (range: 19–65 yr) and median BMI was 23 kg/m2 (range: 18.7–29 kg/m2). Of the 30 patients, 21 had a right-sided UPJO and 9 had a left-sided UPJO. No patients underwent previous UPJO surgery. All patients were symptomatic (100%) and six (20%) had concomitant kidney stones. Median follow-up was 13 mo (range: 3–21 mo).
Age, yr Mean Median Range BMI, kg/m2 Mean Median Range Side affected, no. (%) Right Left Sex, no. (%) Male Female Presence of stones, no. (%) Yes No Symptomatic disease, no. (%) Yes No Type of symptoms, no. (%) Pain UTI Pain plus UTI Preoperative serum creatine, mg/dl Mean Median Range Preoperative eGFR, ml/min/m2 Mean Median Range
39.0 37.0 19.0–65.0 22.7 23.0 18.7–29.0 9 (30.0) 21 (70.0) 12 (40.0) 18 (60.0) 6 (20.0) 24 (80.0) 25 (83.3) 5 (16.7) 24 (80.0) 4 (13.3) 2 (6.7) 0.82 0.75 0.50–1.40 104.8 101.5 58.6–178.0
BMI = body mass index; eGFR = estimated glomerular filtration rate; UTI = urinary tract infections.
3.3.
Efficacy
Two cases (6.6%) required conversion to either standard laparoscopic technique or standard robotic technique: one for malfunctioning of the da Vinci system and the other for adverse anatomic conditions. Median operative time was 160 min (range: 101–300 min). An additional 5-mm trocar was needed to better expose the UPJO in one patient with hepatomegalia and in two cases to retract the descending colon. Crossing vessels were detected in 16 cases (53.3%).
The median postoperative hospital stay was 5 d (range: 3–13 d). The median time to catheter removal was 4 d (range: 2–10 d) and drain removal was 3 d (range: 2–7 d). Patients were mobilized and allowed to resume an oral diet from postoperative day 1. Most of the patients had mild or no pain at discharge (Table 3): 80% of patients had a score of 30 kg/m2 during our learning curve. Moreover, according to a stage 2a study, to better codify the technique we prefer to exclude the difficult cases. In the R-LESS group, all the patients were asymptomatic and all patients have improved renal function postoperatively. No cosmetic evaluation was performed in this study. Khanna et al. [24] performed seven R-LESS pyeloplasties, with two patients requiring conversion to either C-LESS or standard laparoscopic surgery At a mean follow-up of 12.9 mo, six patients reported resolution of symptoms and one patient reported persistent flank pain that was significantly improved after surgery. Again, no cosmetic evaluation was performed in this study. Seideman et al. [25] reported their experience on robotic-assisted pyeloplasty in 10 patients. They concluded that the da Vinci Si robotic platform significantly improve the technical ease of LESS pyeloplasty. Similarly, Tobis et al. [26] described the use of R-LESS pyeloplasty in eight patients. One patient developed a renal fistula that required a nephrostomy tube placement. Hospital stay ranged from 1 to 3 d, with five patients discharged on postoperative day 1. No patient developed symptoms or signs of recurrence, based on diuretic renal scan and either CT scan or renal ultrasound, and all patients were satisfied with the cosmetic results, although no questionnaires were used to objectively evaluate them. The authors concluded that surgeons who perform standard robot-assisted pyeloplasty should place a high value on cosmesis, as future generations of robotic equipment and accessories developed specifically for single-site surgery are being developed and will likely facilitate this technique. However, all of these studies were limited by the low number of patients included, the lack of standardized technique to perform R-LESS pyeloplasty, and the lack of a common platform used. In addition, functional and cosmetic results were not evaluated with a standardized methodology. Conversely, in the current study, 30 R-LESS pyeloplasties were performed using the new da Vinci single-site platform. In both groups, inclusion and exclusion criteria were preoperatively defined and data were prospectively collected. In addition, functional and cosmetic results were evaluated in a standardized fashion, using validated questionnaires. Median hospital stay was 5 d due to the attitude of safety for a new surgical procedure. Twentyeight patients (93.3%) had symptoms resolution after surgery and all of them were satisfied with the cosmetic results, evaluated with the use of validated questionnaires. The limitations of this study mainly are the limited series and short follow-up, although the preliminary results appear promising. Larger series and prospective studies comparing R-LESS pyeloplasty using the new single-port platform with standard robotic pyeloplasty are necessary to properly define the role of this innovative surgical technique. Another limitation was the difficulty of comparing the R-LESS to the standard robotic procedure, due to the selective criteria.
5
Despite gaining experience with several R-LESS applications, we believe that this approach remains more technically challenging relative to conventional robot-assisted pyeloplasty. Although we have successfully performed R-LESS surgery with relatively low complication and conversion rates, we believe that, at present, R-LESS represents a ‘‘stepping stone.’’ Ongoing refinement of technology, particularly the development of novel platforms specific for R-LESS surgery, is critical to promote its routine, widespread use. In this regard, technologies such as the magnetic anchoring and guidance system [27] and flexible [28] and in vivo robotics [29] are attractive technologies on the horizon that may help to overcome some of the limitations of current R-LESS surgery that stem from instrument crowding and relative lack of triangulation. 5.
Conclusions
This study reports the only multi-institutional experience with R-LESS pyeloplasty to date. R-LESS pyeloplasty is a challenging technique, due to still-inadequate instruments (eg, absence of EndoWrist [Intuitive Surgical] technology and monopolar scissors) and the lack of adequate bedside assistance. However, R-LESS technology should be developed as a stepping stone toward a surgical technological evolution. Further studies with longer follow-up are needed to assess the long-term efficacy of this new surgical technique. Author contributions: Nicolo` Maria Buffi had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Buffi, Guazzoni, Cestari, Porpiglia. Acquisition of data: Lista, Larcher, Abrate, Fiori. Analysis and interpretation of data: Lughezzani. Drafting of the manuscript: Buffi, Lista, Abrate, Fiori, Porpiglia. Critical revision of the manuscript for important intellectual content: Lazzeri. Statistical analysis: Fossati, Larcher. Obtaining funding: None. Administrative, technical, or material support: Buffi, Guazzoni. Supervision: Guazzoni, Cestari. Other (specify): None. Financial disclosures: Nicolo` Maria Buffi certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: None Funding/Support and role of the sponsor: None. Acknowledgment statement: The authors wish to thank Dana Kuefner, who helped in editing the audio of the surgery video.
Appendix A. Supplementary data The Surgery in Motion video accompanying this article can be found in the online version at http://dx.doi.org/10.1016/ j.eururo.2014.03.001 and via www.europeanurology.com.
Please cite this article in press as: Buffi NM, et al. Robot-assisted, Single-site, Dismembered Pyeloplasty for Ureteropelvic Junction Obstruction with the New da Vinci Platform: A Stage 2a Study. Eur Urol (2014), http://dx.doi.org/10.1016/j.eururo.2014.03.001
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Please cite this article in press as: Buffi NM, et al. Robot-assisted, Single-site, Dismembered Pyeloplasty for Ureteropelvic Junction Obstruction with the New da Vinci Platform: A Stage 2a Study. Eur Urol (2014), http://dx.doi.org/10.1016/j.eururo.2014.03.001
available at www.sciencedirect.com journal homepage: www.europeanurology.com
Surgery in Motion
Robot-assisted, Single-site, Dismembered Pyeloplasty for Ureteropelvic Junction Obstruction with the New da Vinci Platform: A Stage 2a Study Nicolo` Maria Buffi a,*, Giovanni Lughezzani a, Nicola Fossati a, Massimo Lazzeri a, Giorgio Guazzoni a, Giuliana Lista a, Alessandro Larcher a, Alberto Abrate a, Cristian Fiori b, Andrea Cestari c, Francesco Porpiglia b a
Department of Urology, San Raffaele Turro Hospital, Milan, Italy;
c
Department of Urology, Istituto Auxologico Italiano, Milan, Italy
b
Department of Urology, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy;
Article info
Abstract
Article history: Accepted March 3, 2014 Published online ahead of print on March 13, 2014
Background: Laparoendoscopic single-site surgery (LESS) has gained popularity in urology over the last few years. Objective: To report a stage 2a study of robot-assisted single-site (R-LESS) pyeloplasty for ureteropelvic junction obstruction (UPJO). Design, setting, and participants: This study is an investigative pilot study of 30 consecutive cases of R-LESS pyeloplasty performed at two participating institutions between July 2011 and September 2013. Surgical procedure: Dismembered R-LESS pyeloplasty was performed at two surgical centers. Measurements: Feasibility (conversion rate), safety (complication rate and Clavien-Dindo classification), efficacy (clinical outcome) of the procedure were assessed. Results and limitations: The median patient age was 37 yr (range: 19–65 yr) and median body mass index was 23 kg/m2 (range: 19–29 kg/m2). The median operative time was 160 min (range: 101–300 min), the median postoperative stay was 5 d (range: 3–13 d), and the median time to catheter removal was 3 d (range: 2–10). Two cases required conversion, the first one to standard laparoscopic technique and the second one to standard robotic technique. No intraoperative complications were reported. In three cases, an additional 5-mm trocar was needed. The postoperative complications rate was 26% (n = 8). Most of them were grade 1 complications (n = 4; 13%), followed by grade 2 (n = 3; 10%) and grade 3 (n = 1; 3.3%) complications, according to the Clavien-Dindo classification. One patient needed a surgical reintervention with standard robotic technique 3 d after surgery for urinary leakage. The overall success rate, considered as the resolution of symptoms and the absence of functional impairment at postoperative imaging, was 93.3% (n = 28) at a median follow-up of 13 mo (range: 3–21 mo). The main limitations of this study are the limited number of patients included and the short-term follow-up. Conclusions: Single-site robotic pyeloplasty is a feasible technique in selected patients, with good cosmetic results and excellent short-term clinical outcomes. Prospective studies are needed to further assess its role for the treatment of UPJO. Patient summary: Single-site robot-assisted pyeloplasty is a feasible technique with good cosmetic results and excellent short-term clinical outcomes. # 2014 Published by Elsevier B.V. on behalf of European Association of Urology.
Keywords: Robotic surgery Single site Pyeloplasty Ureteropelvic junction obstruction Please visit www.europeanurology.com and www.urosource.com to view the accompanying video.
* Corresponding author. Department of Urology, San Raffaele Turro Hospital, Vita-Salute San Raffaele University, Via Stamira D’Ancona, 20, 20127 Milan, Italy. Tel. +39 02 2643 7286; Fax: +39 02 2643 7298. E-mail address: buffi[email protected] (N.M. Buffi). http://dx.doi.org/10.1016/j.eururo.2014.03.001 0302-2838/# 2014 Published by Elsevier B.V. on behalf of European Association of Urology.
Please cite this article in press as: Buffi NM, et al. Robot-assisted, Single-site, Dismembered Pyeloplasty for Ureteropelvic Junction Obstruction with the New da Vinci Platform: A Stage 2a Study. Eur Urol (2014), http://dx.doi.org/10.1016/j.eururo.2014.03.001
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EUROPEAN UROLOGY XXX (2014) XXX–XXX
1.
Introduction
The follow-up program included an abdominal ultrasound, urinalysis, and a urine culture after 1 mo, as well as a CT urography and MAG-3
Laparoendoscopic single-site surgery (LESS) has been proposed as an evolutionary step beyond standard laparoscopy and, since its introduction, has been increasingly adopted by urologists worldwide [1,2]. The adoption of this technique was mainly driven by the hypothesis that the minimization of the skin incision to gain access to the abdominal or pelvic cavities may benefit patients in terms of port-related complications, recovery time, postoperative pain, and cosmetic results [3,4]. However, this technique remains highly challenging, even for expert laparoscopic surgeons. Although application of the da Vinci robotic single-port platform (Intuitive Surgical Inc, Sunnyvale, CA, USA) combined with 8-mm standard instruments has the potential to overcome some of these challenges, such as the steep learning curve and difficult intracorporeal suturing, reports to date reveal only a marginal benefit of this approach, largely due to internal and external robotic-arm clashing [5]. More recently, LESS has been merged with robot-assisted surgery (R-LESS) [6] using a new, robotic, single-site platform with 5-mm flexible instruments. Evidence supporting R-LESS pyeloplasty has been limited to a single small case series. Further multicentric studies are required to gain more evidence regarding the effectiveness and feasibility of this technique. We present the first, prospective, multicenter study of R-LESS pyeloplasty with the new da Vinci single-site platform developed within stringent criteria of clinical surgical research.
diuretic renal scan after 6 mo. Ultrasound was repeated annually and an evaluation of symptom relief at each follow-up visit was done. Follow-up visits were done at 1, 3, 6, and 12 mo, and then annually. Criteria for success were clinical resolution of symptoms, no radiologic evidence of obstruction at CT urography, and no functional evidence of obstruction at MAG-3 renal scan.
2.1.
Surgical technique
The surgeons were trained on dry and wet laboratories before starting the first case and had the opportunity to discuss the surgical procedure together. Robotic, single-site pyeloplasty was performed using the new da Vinci single-site robotic surgery platform according to the AndersonHynes technique. In all patients, a double-J (DJ) ureteral stent was positioned retrograde. The stent was removed after approximately 30 d. The new da Vinci single-site robotic surgery platform is a semirigid, robotic operative system designed to work with the da Vinci Si Surgical System (Intuitive Surgical). The system incorporates a multichannel single port that accommodates two curved, robotic cannulas and allows for the passage of interchangeable semirigid instruments that cross each other within the trocar. The instrument entering on the right side 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 of the instrument with the right hand at the right side of the 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 robotcontrolled instruments and optic (a 308 scope down oriented), the specifically designed port allows for the access of an additional one or two conventional laparoscopic entrances for the assistant. The robot-assisted, single-site surgical technique was performed
2.
Materials and methods
using the previously described procedure [12] with a transperitoneal approach [13]. Patients were positioned in a 758 flank position with the
A stage 2a development (ie, investigative, pilot) study was conducted [7].
bed flexed (308) to elevate the surgical area. A double-sterile field was
Between July 2011 and December 2013, we enrolled 30 patients who
prepared to have full access to the target abdominal area, the penis in
underwent R-LESS pyeloplasty for ureteropelvic junction obstruction
males and the vagina in females, adequately providing access to the
(UPJO). Patients were treated at two high-volume laparoscopic and
external urinary meatus to perform the flexible cystoscopy for DJ stent
robotic surgery centers (center 1: San Raffaele Turro Hospital, Milan,
positioning.
Italy; center 2: San Luigi Gonzaga Hospital, Orbassano, Turin, Italy). Indications to surgery were based on the results of imaging
A 2- to 2.5-cm intraumbilical skin incision was performed with a dissection of the musculofascial planes to reach the peritoneal cavity;
techniques, mercaptoacetyltriglycine-3 (MAG-3) diuretic renal scans
2-0 polyglactin holding stitches are placed alongside the programmed,
showing evident obstruction not solved following furosemide injection
vertical fascial incision to mark the anterior fascia, the underlying
(half-life >20 min), and the presence of symptoms (eg, recurrent flank
transversalis fascia, and peritoneum. These are incised, and the
pain, fever, and recurrent upper urinary tract episodes). Exclusion
peritoneal cavity is entered. The da Vinci single-site ports are then
criteria were a body mass index (BMI) >30 kg/m2, previous abdominal
placed and pneumoperitoneum induced through a GelPort (Applied
and renal surgery, an extremely large renal pelvis (ie, pelvis diameter
Medical Resources Corp, Rancho Santa Margarita, CA, USA) inserted into
>6 cm), pelvic kidney, and horseshoe kidney.
the umbilical incision. Difficulties may occur in the introduction of the
Patients signed an informed consent before surgery and were
GelPort into the 2-cm umbilical incision, but could be overcome using
especially made aware of the possibility that the surgery could be
the right method of folding the GelPort and using a Satinsky clamp like a
converted into a traditional robotic or laparoscopic procedure.
shoehorn. The GelPort is then twisted toward the target to align the
The end points of this study were (1) feasibility, expressed as
robotic optic arm. In the docking of the da Vinci system, the camera arm
conversion rate; (2) safety, estimated by complication rate according to
has to remain in line with the target, perpendicular to the GelPort, to
Clavien-Dindo classification [8]; and (3) efficacy, consisting of the
show the insertion of first the second robotic arm, and then the first arm.
functional and symptomatologic success of surgical treatment evaluated
To minimize conflicts between the arms, the first two joints of each arm
with computed tomography (CT) urography and MAG-3 diuretic renal
have to be aligned. Once the system is docked, all arms should be lifted to
scan, visual analog scale (VAS) of pain [9], and good cosmetic results
gain more space. Carbon dioxide is inserted through the camera trocar;
evaluated using a patient scar-assessment scale (PSAS), a 6-item self-
meanwhile, the assistant controls two other, different trocars.
report scale in which items are scored on a numeric rating of 0–10 [10]
The right side of the parietal peritoneum, overlying Gerota’s fascia, is
and a VAS for cosmesis [11]. The latter is a 10-point scale evaluating the
incised and the target structures (the ureter, the dilated renal pelvis, and,
subjective aesthetic judgment of the scar. A higher score means a good
eventually, the aberrant crossing vessels) are exposed. On the left side,
subjective judgment.
typically the white line of Toldt is incised and the left colon is mobilized
Please cite this article in press as: Buffi NM, et al. Robot-assisted, Single-site, Dismembered Pyeloplasty for Ureteropelvic Junction Obstruction with the New da Vinci Platform: A Stage 2a Study. Eur Urol (2014), http://dx.doi.org/10.1016/j.eururo.2014.03.001
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EUROPEAN UROLOGY XXX (2014) XXX–XXX
medially to expose Gerota’s fascia, which is incised, isolating the target structures. Robotic bipolar forceps and monopolar scissors are used to dissect the proximal ureter and the dilated renal pelvis. The stenotic ureteropelvic
Table 1 – Descriptive characteristics of 30 patients affected by ureteropelvic junction obstruction treated with robot-assisted single-site pyleoplasty between July 2011 and December 2013 Preoperative variables
Values
junction was excised; the ureter was then spatulated longitudinally and the pyeloplasty performed according to the Anderson-Hynes technique. The posterior aspect of the anastomosis was performed with a running 5-0 Vicryl suture (Ethicon Endo-Surgery Inc, Cincinnati, OH, USA) RB2 needle. 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 retrograde using a flexible cystoscope to ease the procedure and save time by not modifying the patient’s position and undocking and redocking the robotic arm system. 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 and the anterior aspect of the anastomosis was completed. At the end of the procedure, once complete hemostasis was achieved, a suction drain was left in place. In the case of a crossing vessel, a dismembered pyeloplasty with transposition of the reanastomosed ureter ventral to the vessels was performed. Stone removal was feasible in all cases with a flexible cystoscope though the 10-mm port. Stones are removed using a basket and put into a retrieval bag, which is removed at the end of the surgical procedure.
3.
Results
Demographic characteristics and preoperative data of the population are showed in Table 1. Thirty patients underwent single-site robotic pyeloplasty, 18 were treated in center 1 and 12 in center 2. Median patient age was 37 yr (range: 19–65 yr) and median BMI was 23 kg/m2 (range: 18.7–29 kg/m2). Of the 30 patients, 21 had a right-sided UPJO and 9 had a left-sided UPJO. No patients underwent previous UPJO surgery. All patients were symptomatic (100%) and six (20%) had concomitant kidney stones. Median follow-up was 13 mo (range: 3–21 mo).
Age, yr Mean Median Range BMI, kg/m2 Mean Median Range Side affected, no. (%) Right Left Sex, no. (%) Male Female Presence of stones, no. (%) Yes No Symptomatic disease, no. (%) Yes No Type of symptoms, no. (%) Pain UTI Pain plus UTI Preoperative serum creatine, mg/dl Mean Median Range Preoperative eGFR, ml/min/m2 Mean Median Range
39.0 37.0 19.0–65.0 22.7 23.0 18.7–29.0 9 (30.0) 21 (70.0) 12 (40.0) 18 (60.0) 6 (20.0) 24 (80.0) 25 (83.3) 5 (16.7) 24 (80.0) 4 (13.3) 2 (6.7) 0.82 0.75 0.50–1.40 104.8 101.5 58.6–178.0
BMI = body mass index; eGFR = estimated glomerular filtration rate; UTI = urinary tract infections.
3.3.
Efficacy
Two cases (6.6%) required conversion to either standard laparoscopic technique or standard robotic technique: one for malfunctioning of the da Vinci system and the other for adverse anatomic conditions. Median operative time was 160 min (range: 101–300 min). An additional 5-mm trocar was needed to better expose the UPJO in one patient with hepatomegalia and in two cases to retract the descending colon. Crossing vessels were detected in 16 cases (53.3%).
The median postoperative hospital stay was 5 d (range: 3–13 d). The median time to catheter removal was 4 d (range: 2–10 d) and drain removal was 3 d (range: 2–7 d). Patients were mobilized and allowed to resume an oral diet from postoperative day 1. Most of the patients had mild or no pain at discharge (Table 3): 80% of patients had a score of 30 kg/m2 during our learning curve. Moreover, according to a stage 2a study, to better codify the technique we prefer to exclude the difficult cases. In the R-LESS group, all the patients were asymptomatic and all patients have improved renal function postoperatively. No cosmetic evaluation was performed in this study. Khanna et al. [24] performed seven R-LESS pyeloplasties, with two patients requiring conversion to either C-LESS or standard laparoscopic surgery At a mean follow-up of 12.9 mo, six patients reported resolution of symptoms and one patient reported persistent flank pain that was significantly improved after surgery. Again, no cosmetic evaluation was performed in this study. Seideman et al. [25] reported their experience on robotic-assisted pyeloplasty in 10 patients. They concluded that the da Vinci Si robotic platform significantly improve the technical ease of LESS pyeloplasty. Similarly, Tobis et al. [26] described the use of R-LESS pyeloplasty in eight patients. One patient developed a renal fistula that required a nephrostomy tube placement. Hospital stay ranged from 1 to 3 d, with five patients discharged on postoperative day 1. No patient developed symptoms or signs of recurrence, based on diuretic renal scan and either CT scan or renal ultrasound, and all patients were satisfied with the cosmetic results, although no questionnaires were used to objectively evaluate them. The authors concluded that surgeons who perform standard robot-assisted pyeloplasty should place a high value on cosmesis, as future generations of robotic equipment and accessories developed specifically for single-site surgery are being developed and will likely facilitate this technique. However, all of these studies were limited by the low number of patients included, the lack of standardized technique to perform R-LESS pyeloplasty, and the lack of a common platform used. In addition, functional and cosmetic results were not evaluated with a standardized methodology. Conversely, in the current study, 30 R-LESS pyeloplasties were performed using the new da Vinci single-site platform. In both groups, inclusion and exclusion criteria were preoperatively defined and data were prospectively collected. In addition, functional and cosmetic results were evaluated in a standardized fashion, using validated questionnaires. Median hospital stay was 5 d due to the attitude of safety for a new surgical procedure. Twentyeight patients (93.3%) had symptoms resolution after surgery and all of them were satisfied with the cosmetic results, evaluated with the use of validated questionnaires. The limitations of this study mainly are the limited series and short follow-up, although the preliminary results appear promising. Larger series and prospective studies comparing R-LESS pyeloplasty using the new single-port platform with standard robotic pyeloplasty are necessary to properly define the role of this innovative surgical technique. Another limitation was the difficulty of comparing the R-LESS to the standard robotic procedure, due to the selective criteria.
5
Despite gaining experience with several R-LESS applications, we believe that this approach remains more technically challenging relative to conventional robot-assisted pyeloplasty. Although we have successfully performed R-LESS surgery with relatively low complication and conversion rates, we believe that, at present, R-LESS represents a ‘‘stepping stone.’’ Ongoing refinement of technology, particularly the development of novel platforms specific for R-LESS surgery, is critical to promote its routine, widespread use. In this regard, technologies such as the magnetic anchoring and guidance system [27] and flexible [28] and in vivo robotics [29] are attractive technologies on the horizon that may help to overcome some of the limitations of current R-LESS surgery that stem from instrument crowding and relative lack of triangulation. 5.
Conclusions
This study reports the only multi-institutional experience with R-LESS pyeloplasty to date. R-LESS pyeloplasty is a challenging technique, due to still-inadequate instruments (eg, absence of EndoWrist [Intuitive Surgical] technology and monopolar scissors) and the lack of adequate bedside assistance. However, R-LESS technology should be developed as a stepping stone toward a surgical technological evolution. Further studies with longer follow-up are needed to assess the long-term efficacy of this new surgical technique. Author contributions: Nicolo` Maria Buffi had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Buffi, Guazzoni, Cestari, Porpiglia. Acquisition of data: Lista, Larcher, Abrate, Fiori. Analysis and interpretation of data: Lughezzani. Drafting of the manuscript: Buffi, Lista, Abrate, Fiori, Porpiglia. Critical revision of the manuscript for important intellectual content: Lazzeri. Statistical analysis: Fossati, Larcher. Obtaining funding: None. Administrative, technical, or material support: Buffi, Guazzoni. Supervision: Guazzoni, Cestari. Other (specify): None. Financial disclosures: Nicolo` Maria Buffi certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: None Funding/Support and role of the sponsor: None. Acknowledgment statement: The authors wish to thank Dana Kuefner, who helped in editing the audio of the surgery video.
Appendix A. Supplementary data The Surgery in Motion video accompanying this article can be found in the online version at http://dx.doi.org/10.1016/ j.eururo.2014.03.001 and via www.europeanurology.com.
Please cite this article in press as: Buffi NM, et al. Robot-assisted, Single-site, Dismembered Pyeloplasty for Ureteropelvic Junction Obstruction with the New da Vinci Platform: A Stage 2a Study. Eur Urol (2014), http://dx.doi.org/10.1016/j.eururo.2014.03.001
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EUROPEAN UROLOGY XXX (2014) XXX–XXX
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Please cite this article in press as: Buffi NM, et al. Robot-assisted, Single-site, Dismembered Pyeloplasty for Ureteropelvic Junction Obstruction with the New da Vinci Platform: A Stage 2a Study. Eur Urol (2014), http://dx.doi.org/10.1016/j.eururo.2014.03.001
