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Does the body weight influence the outcome in children treated with robotic pyeloplasty?
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Journal of Pediatric Urology (xxxx) xxx xxx
Does the body weight influence the outcome in children treated with robotic pyeloplasty? a
Department of Pediatric Urology, University of Florence, Meyer Hospital, Florence, Italy
Lorenzo Masieri a,b,*, Simone Sforza a,b, Antonio Andrea Grosso a,b, Chiara Cini a, Lorenzo Viola a, Riccardo Tellini b, Andrea Mari b, Fabrizio Di Maida b, Andrea Minervini b, Marco Carini b
b
Department of Oncologic, Minimally-Invasive Urology and Andrology, Careggi Hospital, University of Florence, Italy
* Corresponding author. Department of Pediatric Surgery, Pediatric Urology Unit, Anna Meyer Children’s Hospital, Viale Pieraccini 24, 50139 Florence, Italy. Tel.: þ39 3387981669; fax: þ3905556621. [email protected] (L. Masieri) Keywords Minimal invasive surgery; Pediatric; Outcome; Anderson Hynes pyeloplasty; Complication Received 8 May 2019 Accepted 24 October 2019 Available online xxx
Summary Introduction To investigate the influence of the body weight on periand postoperative outcome in a series of pediatric patients with a diagnosis of ureteroepelvic junction obstruction (UPJO) treated with robot-assisted laparoscopic pyeloplasty (RALP) at a single tertiary referral center. Objective In this study, outcomes of RALP in children divided according to the weight are evaluated. Study design Sixty-one consecutive patients treated with RALP from January 2016 to May 2019 were recorded retrospectively and divided according to their weight: group A < 15 kg, group B 15 kg and were included in this study. Eligible criteria for surgery were symptomatic UPJO, worsening of hydronephrosis, or obstructive pattern at renogram. Success criteria were the reduction of the hydronephrosis at imaging and the absence of flank pain. All procedures were performed by one expert robotic surgeon. Results 18 patients were included in group A (median weight 12 kg) and 43 patients in group B (median weight 33 kg). The median (IQR) operative was 95 (90e120) for group A compared to 90 (85e110) of control group. No
significant difference has been found (P Z 0.93). We registered one (5.6%) Clavien 3b complication (omental hernia after removal of the drainage requiring surgical correction) and two (4.7%) Clavien 2 complication in group B (urinary infections). No difference has been found in the length of hospital stay, length of catheterization, and duration of procedure between the groups (P > 0.05). At a median follow-up of 23 months (IQR 9e27 vs 9e33), the success rate was comparable between the two groups (94.4% vs 97.7%; P Z 0.51). Relapse was recorded in one child per group and both required nephrostomy placement. Discussion Our study tried to fill the gaps in the evidence on the feasibility of RALP in low-weight children reporting favorable peri-operative and long-term outcomes; however, this study shows some intrinsic limitations. The relatively small numbers of patients in the <15 kg may have underpowered the comparison with heavier patients. Moreover, only two patients were <10 kg so that no definitive conclusions on the safety and feasibility of RALP in this cohort of patients can be drawn. Conclusion RALP in children <15 kg was feasible and effective to treat UPJO with superimposable results to heavier counterparts. In our experience, the need for a different trocar placement and limited space in patients <15 kg did not affect peri-operative and functional outcomes.
Summary Fig. https://doi.org/10.1016/j.jpurol.2019.10.023 1477-5131/ª 2019 Published by Elsevier Ltd on behalf of Journal of Pediatric Urology Company.
Please cite this article as: Masieri L et al., Does the body weight influence the outcome in children treated with robotic pyeloplasty?, Journal of Pediatric Urology, https://doi.org/10.1016/j.jpurol.2019.10.023
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Introduction Ureteroepelvic junction obstruction (UPJO) is the most common congenital ureteral anomaly, occurring in 1 per 20,000 newborns [1]. Before the advent of maternal ultrasonography (US), UPJO was usually detected for signs and symptoms such as abdominal mass, pain, or unexplained urinary symptoms in adult patients [2]. In contrast, the incidental detection of UPJO by the prenatal US is currently the most common mode of presentation in children, who are often asymptomatic at the moment of the diagnosis [3]. This change has resulted in a significant downward shift in the age of pyeloplasty. Open dismembered pyeloplasty, originally described by Anderson and Hynes in 1949, is the most common surgical procedure performed to treat UPJO either in pediatric and adult’s field with a success rate from 90% to 100% [4]. In recent years, minimally invasive surgery (MIS), such as laparoscopy-assisted pyeloplasty (LP) and more recently robot-assisted laparoscopic pyeloplasty (RALP), has emerged as a valid alternative to the open surgery also in younger patients [5,6]. In particular thanks to the 3D imagines and the endowrist technologies RALP offers not only the advantages to be minimally invasive but appeared to be the leader technique to perform upper urinary tract reconstructive surgery [7e9]. If in the initial phase RALP in pediatric field was confined to school-aged children and adolescent (most of the studies describe this subset of population [8e11]), nowadays robotic surgeons have begun to expand its application even in younger infants facing with the challenge of smaller body size and lighter weight [12]. Although other authors have already reported encouraging outcomes of RALP in this new group of patients, setting new limits in terms of age and weight, its feasibility is still debated [13,14]. In this line, this study wants to compare the safety and efficacy of RALP in infants weighing less than 15.0 kg matched with a cohort of children 15.0 kg performed in a referral tertiary center by a single expert surgeon.
Patients and methods Study population We retrospectively reviewed our prospectively collected clinical data to select consecutive patients with UPJO treated with RALP from January 2016 to May 2019 at a single tertiary referral center. We collected and evaluated data from 61 consecutive patients of age under 18 who underwent RALP following the Anderson-Hynes dismembered technique. Patients <1 year old were excluded due to our anesthesiologic protocol and were submitted to open or minilaparoscopic pyeloplasty [15]. All the surgeries were performed by a single expert robotic surgeon who comes from the adult urology field performing robotic procedures since 2010 and with more than 200 cases for a year in the recent period. Eligible for surgery were patients with symptoms and/or typical obstruction aspects at imaging using US. All patients with suspected UPJO were submitted to dynamic renal
L. Masieri et al. scintigraphy that revealed retention of RPh (cumulative renographic curves) after i.v. administration of the diuretic (0.5 mg/kg of Furosemide) at the 20th minute persisted or decreased by less than 50%. After met the inclusion criteria, patients were further classified according to their weight: children who weighed less than 15.0 kg constituted group A and children weighing 15.0 kg or more constituted the control group (group B). Patients characteristics pre-operatively collected were age in months, gender, side of the obstruction, presence of anatomic variants, and crossing vessels. Anterioreposterior diameter of the pelvis (APD) was pre-operatively evaluated. Outcome parameters measured included operative time, length of hospital stay (LOS), reduction of ADP on US, postoperative complications, hospital readmission, and relapse. Total operative time is composed of set-up time and console operative time. Set-up time was defined as the time from skin incision up to the beginning of the surgery at the operative console and included trocar positioning, docking of the robotic system, and skin suturing after completing the procedure. Console operative time was defined as the time spent at the robotic console. The severity of complications was graded according to the modified Clavien classification system [16]. A scheduled follow-up has been conducted at 1 month after stent removal and then at 6 and 12 months in the absence of symptoms. The success was defined as the reduction of hydronephrosis at US and no symptoms. Conversely, patients were classified as failures if (a) their postoperative US demonstrated persistent hydronephrosis with or without symptoms or (b) they had persistent symptoms alone or (c) they required further (endoscopic or surgical) procedures after surgery. To confirm the diagnosis of failures an Isotopic renography was done. All follow-up data were recorded using specific questionnaires and assessed in dedicated ambulatories at our tertiary referral center by medical doctors.
Surgical technique After positioning an 8Ch Foley catheter, the patient was placed in an oblique position and brought to the edge of the table. Gel pillows or pads were used to elevate the side to be treated and to protect pressure points. The ipsilateral arm was positioned near the head, and the patient was secured to the bed across the chest and legs. Trocars were usually placed as far apart as possible to reduce collisions. In detail, first of all, camera trocar (10 mm for Si device and 8 mm for Xi device) was positioned in the umbilicus with a mini-open incision, and pneumoperitoneum was induced with a pressure of 8e10 mmHg according to the patient’s weight; hereafter, the two robotic arms (8 mm for both platforms) were both placed approximately 5e7 cm away from the camera port, in a line perpendicular to an ideal axis passing through the umbilicus and the UPJ, as a sort of ‘kite-like’ appearance (see the picture on the abstract section). Moreover, a slight traction of trocars, tenting the abdominal wall, was strongly useful to create some extra room and have adequate working space. An additional
Please cite this article as: Masieri L et al., Does the body weight influence the outcome in children treated with robotic pyeloplasty?, Journal of Pediatric Urology, https://doi.org/10.1016/j.jpurol.2019.10.023
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Results from robotic pyeloplasty
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Fig. 1 Design of port placement according to kyte-like configuration.
5 mm trocar for the bedside assistant was regularly placed and served for stitches passage, suction, etc. (see Figs. 1 and 2). The robot was docked on the omolateral bedside of the operated kidney in all patients. After mobilization of the hepatic or splenic flexure of the colon, the ureter was identified high in the retroperitoneum and followed toward the pelvis. The transmesocolic window was used only on the left side, when feasible. Gerota’s fascia was opened longitudinally and the ureteropelvic junction was identified, and its surface was cleared to identify any polar crossing vessels. The renal pelvis and the ureter were dissected to ensure a tension-free anastomosis. The renal pelvis around the UPJ was incised and left attached to the upper ureter to serve as a handle and avoid possible injuries on the anastomotic tissues. The ureter was cut and spatulated longitudinally until it was wide enough and the pyeloplasty was performed according to the Anderson-Hynes technique using 6-0 monocryl anterior and posterior running sutures after the first stitch on the ureteral V was positioned similar to our technique reported in the adult [17]. The posterior aspect of the anastomosis was first performed, then a double J stent was inserted and the anterior part was completed. To avoid the emission of the double J stent outside the urethra we filled the bladder in all the patients of group A. According to surgeon preference, abdominal drainage was placed at the end of the procedure; usually, it was placed in case of redo procedure or in case of surgeon perception of the increased complexity of the surgery [18]. In all patients, the ureteral stent has been removed 1 month postoperatively under anesthesia.
Statistical analysis Statistical analysis was performed using SPSS 20.0 (IBM Corporation, Armonk, New York, USA). Categorical, continuous parametric and not-parametric variables were reported as frequencies and proportions, mean and standard deviation, or as median and interquartile range (IQR), respectively. Unpaired t-test, ManneWhitney test, and Pearson’s chi-squared test were used to compare variables, as appropriate. Statistical significance in this study was set as P 0.05.
Fig. 2
Kyte-like port placement.
Results Overall, 61 patients were included in the analysis and are summarized in Table 1. A total of 18 (29%) children constituted group A (weight < 15.0 kg). 8 (44.4%) were male; the median age was 23 months (IQR 13e30), and median weight was 12 kg (IQR 11e13.8; the two extreme weights were 9 and 14 kg). None of them showed anatomical kidney variance. Symptoms have been recorded in 11 (61.1%) cases with flank pain, nausea, and vomiting (Dietl’s crisis) as the most representatives. The median APD measured on US at the moment of diagnosis was 20 mm (IQR 20e32). One patient of 13 months (11 kg) (7.1%) previously received an ipsilateral open pyeloplasty at 2 months. A total of 43 (71%) young patients constituted the control group (group B) with two cases of redo pyeloplasty. 24 (55.8%) were male. The median age was 105 months (IQR 88e154), and the median weight was 33 kg (IQR 28e50; the two extreme weights were 15 and 67 kg). Different anatomical kidney variance was identified in 11 (25.6%) children: 3 (6.9%) duplex collecting system, 4 (9.3%) horseshoe kidneys, 3 (6.9%) abnormal renal rotation, and 1 (2.3%) patient with congenital solitary kidney. The presence of symptoms was recorded in 38 (88.3%) cases with flank pain as the most common, and the difference between the two groups has been found significant (P Z 0.01). In Group B, two patients (4.6%) previously received an ipsilateral open pyeloplasty at 1 and 6 months. The median APD at the diagnosis was 30 mm (range 24e43) with no significant difference between the two groups (P Z 0.45). Peri- and postoperative data are summarized in Table 2. The median (IQR) operative, set-up time and console time were, respectively, 95 (120), 20 (15e25), 75 (70e90) for group A compared to 90 (85e110), 20 (15e25), 73 (65e80) of control group. No significant difference has been found (P > 0.05). No procedures were converted to open or laparoscopic surgery in both groups and only one major complication occurred during hospitalization and it was a case of omental hernia (Clavien 3b) after removal of the drainage requiring surgical correction under general sedation (group A; 5.6%).
Please cite this article as: Masieri L et al., Does the body weight influence the outcome in children treated with robotic pyeloplasty?, Journal of Pediatric Urology, https://doi.org/10.1016/j.jpurol.2019.10.023
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1.e4 Table 1
L. Masieri et al. Pre-operative data of patient.
Pre-operative data Gender, n. %
Male Female Side, n. % Right Left Age (months), median IQR Weight (kg), median IQR Symptoms at diagnosis, n. % Anatomic variant, n. % Crossing vessels, n. % Pre-operative nephrostomy, n. % APD pre-operative, median IQR
kg Z (n; %) kg < 15 (18; 29%)
kg > 15 (43; 71%)
P-value (<0.05)
8 10 6 12 23 12 11 1 3 1
44.4% 55.6% 33.3% 66.7% 13e30 11e13.8 61.1% 5.6% 16.7% 7.1%
24 19 19 24 105 33 38 11 18 2
55.8% 44.2% 44.2% 55.8% 88e154 28e50 88.4% 25.6% 41.9% 5.6%
0.41
0.01 0.73 0.59 0.83
20
20e32
30
24e43
0.45
0.61
APD, anterioreposterior pelvic diameter.
Table 2
Surgical and postoperative data.
Surgical and postoperative data
kg < 15 (18; 29%)
kg > 15 (43; 71%)
P-value (<0.05)
Overall operative time, median IQR Console time, median IQR Set-up time, median IQR Drainage, n. % Yes No Catheter, median IQR APD postoperative, median IQR LOS, median IQR Follow-up months, median IQR Readmission, n. % Relapse, n. % Complication, n. %
95
90e120
90
85e110
0.92
75 20 10 8 3 12
70e90 15e25 55.6% 44.4% 3e3 9e15
75 20 15 28 3 12
65e80 15e25 34.9% 65.1% 3e3 10e15
0.34 0.45 0.13
4 23
3e4 9e27
4 23
3e4 9e33
0.66 0.97
1 1 1
5.6% 5.6% 5.6%
1 1 2
2.3% 2.3% 4.7%
0.51 0.51 0.88
0.92 0.91
APD, anterioreposterior pelvic diameter; LOS, length of stay.
In group B, two (4.7%) patients showed postoperative urinary tract febrile infection successfully treated with broad-spectrum antibiotics (Clavien 2). The median hospital stay was 4 days in both groups (IQR 3e4), and all the patients had the catheter removed in the third postoperative day. At the first month control, after stent removal, a renal US was conducted and revealed a decrease of hydronephrosis in all patients but one belonging to group A. The median (IQR) postoperative APD was 12 mm for both groups (9e15 in group A; 10e15 in group B) with no significant difference found (P Z 0.66). At a median follow-up of 23 months (IQR 9e23 for group A and 9e33 for group B), the success rate was comparable between the two groups (94.4% vs 97.7%; P Z 0.51). Relapse was recorded in one (5.6%) child in group A, who prior received an open pyeloplasty (redo pyeloplasty), presenting persistent hydronephrosis (ADP Z 28 mm) and in one (2.3%) child in group B. Both required nephrostomy placement.
Discussion Although most prenatally diagnosed hydronephroses resolve spontaneously, a subset of patients (10%) presents persistent UPJO requiring surgical intervention [1]. Since the initial report in 1995, this statement has rapidly evolved and now the latest European Association of Urology/European Society for Pediatric Urology guidelines on pediatric urology state that in experienced hands, the success rates (90e95%) of minimally invasive pyeloplasty are similar to the open classical approach [19] in parallel several series focusing on feasibility of robotic surgery in children have been reported. Minnillo et al. in a large single-institution study, assessed outcomes of 155 pediatric patients undergoing RALP and found a success rate of 96%, with only 3% of patients requiring reoperation for recurrent obstruction [20]. Indeed, Silay et al. in a large multicentric experience of
Please cite this article as: Masieri L et al., Does the body weight influence the outcome in children treated with robotic pyeloplasty?, Journal of Pediatric Urology, https://doi.org/10.1016/j.jpurol.2019.10.023
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Results from robotic pyeloplasty nearly 600 patients treated with MIS pyeloplasty, reported a success rate of 99.5% and 97.3%, respectively, for RALP and laparoscopic approach [19]. Cundy et al. included in a recent meta-analysis 13 observational studies, while no randomized controlled trials compared the outcomes of RALP, LP, and OP techniques in children [21]. Overall success (improvement or resolution of hydronephrosis) rates were similar in the three groups and >95%, with either an equivalent or shorter LOS in the RALP cohort [22,23]. As well the favorable outcomes of RALP are reported and documented, the surgeons tried to push the limits of RALP toward ever younger and lighter children. Ballouhey et al. reported a large series of robotic surgery divided according to the weight (<15 and >15 kg) that included 35 robotassisted pyeloplasty without need to conversion to open or laparoscopic approach but with a slightly increase operative time [24]. Ganpule et al. attempted to evaluate the peri-operative outcome of MIS pyeloplasty in children less than 20 kg reporting more favorable results in the robotic group (19 patients) for what concerns the operative time and the LOS [25]. Recently, Kawal et al. compared the efficacy of RALP in children with a median weight of 9.9 kg with an older and heavier (median weight 27.1) cohort. The success rate did not significatively change in either group (94.1% in the lighter group and 96.2% in the other group) [14]. Although the study of Kawal represents one of the largest series available on this topic, it shows some limitations that could have potentially influenced the overall success rate including a short follow-up and the presence of some exclusion criteria while our series is composed by all consecutive patients during the study period. In our experience, none of the patients required conversion to open surgery or experienced intra-operative complications and all demonstrated improvement in hydronephrosis with an overall success rate of 98%. Indeed, it must be noted that some authors have reported the safety and feasibility of RALP in <1 year and <10 kg children; however, the evidence is still weak and indication to RALP in these patients seems to be limited [13,26]. Another topic that in the past period limited robotic procedures in small children consisted of trocar placement due to the restricted space that often causes conflicts between arms; some opponents, indeed, argued that this limitation increases significantly the operative time. Ballouhey et al. proposed a recent comparison of children based on weight undergoing robotic urological surgery and found that weight <15 kg was associated with longer set-up times, with similar surgical times and outcomes [24]. Finkelstein et al. proposed that a distance 13 cm between both anterior superior iliac spines and a puboxyphoid distance 15 cm was associated with greater instrument collisions during surgery in infants and suggested these distances as cut-offs when considering robotic surgery in infants [27]. In our experience in both groups we did not find any difference in operative time, set-up time, or intraoperative limitations between the infants weighing <15.0 kg and 15.0 Kg. Si and Xi devices were both employed according to the availability of the operating room and no distinction was made between the two groups. Although Xi system allows a better maneuverability thanks to its 8 mm trocar ports compared to Si device, we believe
1.e5 that the correct bed positioning of the patient and a reproducible trocar placement method (‘kite-like’ configuration) together with the use of a ‘tent effect,’ are sufficient to achieve an adequate working space and to avoid prolonged operative set up and operative times, regardless of patient’s weight and age. However, this study shows some intrinsic limitations. The relatively small numbers of patients in the <15 kg may have underpowered the comparison with heavier patients. Indeed, the procedures were all performed by an experienced robotic surgeon in a tertiary referral center; as such, our results might not be applicable to all surgeon- or center-related scenarios. Moreover, only two patients were <10 kg so that no definitive conclusions on the safety and feasibility of RALP in this cohort of patients can be drawn. Despite these limitations, our study tried to fill the gaps in the evidence on the feasibility of RALP in low-weight children reporting favorable peri-operative and long-term outcomes. In this challenging scenario, the recently introduced da Vinci single-port robot-assisted platform may further increase the benefits of robotic surgery and may also contribute to widening its indications in the pediatric population [12,28].
Conclusion This study demonstrates that robotic surgery is feasible and safe in children weighing less than 15.0 kg and corroborates the ongoing trend toward the increasing adaptation of RALP for the entire pediatric population. A larger study with longer follow-up is necessary to evaluate the surgical and cosmetic outcomes (Summary Figure, Figs. 1 and 2).
Author statements Conflict of interests None.
Funding None.
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Please cite this article as: Masieri L et al., Does the body weight influence the outcome in children treated with robotic pyeloplasty?, Journal of Pediatric Urology, https://doi.org/10.1016/j.jpurol.2019.10.023
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1.e6 [6] O’Reilly PH, Brooman PJ, Mak S, et al. The long-term results of Anderson-Hynes pyeloplasty. BJU Int 2001;87(4):287e9. [7] Varda BK, Wang Y, Chung BI, et al. Has the robot caught up? National trends in utilization, perioperative outcomes, and cost for open, laparoscopic, and robotic pediatric pyeloplasty in the United States from 2003 to 2015. J Pediatr Urol February 2018. https: //doi.org/10.1016/j.jpurol.2017.12.010. [8] Peters CA. Pediatric robot-assisted pyeloplasty. J Endourol 2011;25(2):179e85. https://doi.org/10.1089/end.2010.0597. [9] Hollis MV, Cho PS, Yu RN. Pediatric robot-assisted laparoscopic pyeloplasty. Am J Robot Surg 2015;2(1):1e8. https: //doi.org/10.1166/ajrs.2015.1024. [10] Sorensen MD, Johnson MH, Delostrinos C, Bice JB, Grady RW, Lendvay TS. Initiation of a pediatric robotic surgery program: institutional challenges and realistic outcomes. Surg Endosc 2010;24(11):2803e8. https://doi.org/10.1007/s00464-0101052-8. [11] Bansal D, Defoor WR, Reddy PP, Minevich EA, Noh PH. Complications of robotic surgery in pediatric urology: a single institution experience. Urology 2013;82(4):917e21. https: //doi.org/10.1016/j.urology.2013.05.046. [12] Subramaniam R. Current use of and indications for robotassisted surgery in paediatric urology. Eur Urol Focus 2018; 4(5):662e4. https://doi.org/10.1016/j.euf.2018.08.020. [13] Kafka IZ, Kocherov S, Jaber J, Chertin B. Pediatric roboticassisted laparoscopic pyeloplasty (RALP): does weight matter? Pediatr Surg Int 2019;0(0):0. https: //doi.org/10.1007/s00383-019-04435-y. [14] Kawal T, Srinivasan AK, Shrivastava D, et al. Pediatric roboticassisted laparoscopic pyeloplasty: does age matter? J Pediatr Urol 2018. https://doi.org/10.1016/j.jpurol.2018.04.023. [15] Masieri L, Sforza S, Cini C, et al. Minilaparoscopic versus open pyeloplasty in children less than 1 year. J Laparoendosc Adv Surg Tech A June 2019:0586. https://doi.org/10.1089/lap.2018.0586. lap.2018. [16] Dindo D, Demartines N, Clavien P-A. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004;240(2): 205e13. https://doi.org/10.1097/01.sla.0000133083.54934. [17] Masieri L, Sforza S, Mari A, et al. Robot-assisted pyeloplasty for ureteropelvic junction obstruction: experience from a tertiary referral centre. Minerva Urol Nefrol February 2019. https://doi.org/10.23736/S0393-2249.19.03328-9. [18] Sforza S, Di Maida F, Mari A, et al. Is a drainage placement still necessary after robotic reconstruction of the upper urinary tract in children? Experience from a tertiary referral center. J Laparoendosc Adv Surg Tech July 2019:0302. https://doi.org/10.1089/lap.2019.0302. lap.2019.
L. Masieri et al. [19] Silay MS, Spinoit A, Undre S, et al. Global minimally invasive pyeloplasty study in children: results from the pediatric urology expert group of the european association of urology young academic urologists working party. J Pediatr Urol 2016. https://doi.org/10.1016/j.jpurol.2016.04.007. [20] Minnillo BJ, Cruz JAS, Sayao RH, et al. Long-term experience and outcomes of robotic assisted laparoscopic pyeloplasty in children and young adults. J Urol 2011;185(4):1455e60. https: //doi.org/10.1016/j.juro.2010.11.056. [21] Cundy TP, Harling L, Hughes-Hallett A, et al. Meta-analysis of robot-assisted vs conventional laparoscopic and open pyeloplasty in children. BJU Int 2014;114(4):582e94. http://www. ncbi.nlm.nih.gov/pubmed/25383399. [Accessed 21 January 2019]. [22] Dangle PP, Kearns J, Anderson B, Gundeti MS. Outcomes of infants undergoing robot-assisted laparoscopic pyeloplasty compared to open repair. J Urol 2013;190(6):2221e7. https: //doi.org/10.1016/j.juro.2013.07.063. [23] Bansal D, Cost NG, DeFoor WR, et al. Infant robotic pyeloplasty: comparison with an open cohort. J Pediatr Urol 2014; 10(2):380e5. https://doi.org/10.1016/j.jpurol.2013.10.016. [24] Ballouhey Q, Villemagne T, Cros J, et al. A comparison of robotic surgery in children weighing above and below 15.0 kg: size does not affect surgery success. Surg Endosc 2015;29(9): 2643e50. https://doi.org/10.1007/s00464-014-3982-z. [25] Ganpule A, Jairath A, Singh A, Mishra S, Sabnis R, Desai M. Robotic versus conventional laparoscopic pyeloplasty in children less than 20 kg by weight: single-center experience. World J Urol 2015;33(11):1867e73. https: //doi.org/10.1007/s00345-015-1694-1. [26] Kutikov A, Resnick M, Casale P. Laparoscopic pyeloplasty in the infant younger than 6 months - is it technically possible? J Urol 2006;175(4):1477e9. https://doi.org/10.1016/S00225347(05)00673-7. [27] Finkelstein JB, Levy AC, Silva MV, Murray L, Delaney C, Casale P. How to decide which infant can have robotic surgery? Just do the math. J Pediatr Urol 2015;11(4). https: //doi.org/10.1016/j.jpurol.2014.11.020. 170.e1-170.e4. [28] Kaouk J, Bertolo R. Single-site robotic platform in clinical practice: first cases in the USA. Minerva Urol Nefrol January 2019. https://doi.org/10.23736/S0393-2249.19.03384-8.
Appendix A. Supplementary data Supplementary data to this article can be found online at https://doi.org/10.1016/j.jpurol.2019.10.023.
Please cite this article as: Masieri L et al., Does the body weight influence the outcome in children treated with robotic pyeloplasty?, Journal of Pediatric Urology, https://doi.org/10.1016/j.jpurol.2019.10.023
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Journal of Pediatric Urology (xxxx) xxx xxx
Does the body weight influence the outcome in children treated with robotic pyeloplasty? a
Department of Pediatric Urology, University of Florence, Meyer Hospital, Florence, Italy
Lorenzo Masieri a,b,*, Simone Sforza a,b, Antonio Andrea Grosso a,b, Chiara Cini a, Lorenzo Viola a, Riccardo Tellini b, Andrea Mari b, Fabrizio Di Maida b, Andrea Minervini b, Marco Carini b
b
Department of Oncologic, Minimally-Invasive Urology and Andrology, Careggi Hospital, University of Florence, Italy
* Corresponding author. Department of Pediatric Surgery, Pediatric Urology Unit, Anna Meyer Children’s Hospital, Viale Pieraccini 24, 50139 Florence, Italy. Tel.: þ39 3387981669; fax: þ3905556621. [email protected] (L. Masieri) Keywords Minimal invasive surgery; Pediatric; Outcome; Anderson Hynes pyeloplasty; Complication Received 8 May 2019 Accepted 24 October 2019 Available online xxx
Summary Introduction To investigate the influence of the body weight on periand postoperative outcome in a series of pediatric patients with a diagnosis of ureteroepelvic junction obstruction (UPJO) treated with robot-assisted laparoscopic pyeloplasty (RALP) at a single tertiary referral center. Objective In this study, outcomes of RALP in children divided according to the weight are evaluated. Study design Sixty-one consecutive patients treated with RALP from January 2016 to May 2019 were recorded retrospectively and divided according to their weight: group A < 15 kg, group B 15 kg and were included in this study. Eligible criteria for surgery were symptomatic UPJO, worsening of hydronephrosis, or obstructive pattern at renogram. Success criteria were the reduction of the hydronephrosis at imaging and the absence of flank pain. All procedures were performed by one expert robotic surgeon. Results 18 patients were included in group A (median weight 12 kg) and 43 patients in group B (median weight 33 kg). The median (IQR) operative was 95 (90e120) for group A compared to 90 (85e110) of control group. No
significant difference has been found (P Z 0.93). We registered one (5.6%) Clavien 3b complication (omental hernia after removal of the drainage requiring surgical correction) and two (4.7%) Clavien 2 complication in group B (urinary infections). No difference has been found in the length of hospital stay, length of catheterization, and duration of procedure between the groups (P > 0.05). At a median follow-up of 23 months (IQR 9e27 vs 9e33), the success rate was comparable between the two groups (94.4% vs 97.7%; P Z 0.51). Relapse was recorded in one child per group and both required nephrostomy placement. Discussion Our study tried to fill the gaps in the evidence on the feasibility of RALP in low-weight children reporting favorable peri-operative and long-term outcomes; however, this study shows some intrinsic limitations. The relatively small numbers of patients in the <15 kg may have underpowered the comparison with heavier patients. Moreover, only two patients were <10 kg so that no definitive conclusions on the safety and feasibility of RALP in this cohort of patients can be drawn. Conclusion RALP in children <15 kg was feasible and effective to treat UPJO with superimposable results to heavier counterparts. In our experience, the need for a different trocar placement and limited space in patients <15 kg did not affect peri-operative and functional outcomes.
Summary Fig. https://doi.org/10.1016/j.jpurol.2019.10.023 1477-5131/ª 2019 Published by Elsevier Ltd on behalf of Journal of Pediatric Urology Company.
Please cite this article as: Masieri L et al., Does the body weight influence the outcome in children treated with robotic pyeloplasty?, Journal of Pediatric Urology, https://doi.org/10.1016/j.jpurol.2019.10.023
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Introduction Ureteroepelvic junction obstruction (UPJO) is the most common congenital ureteral anomaly, occurring in 1 per 20,000 newborns [1]. Before the advent of maternal ultrasonography (US), UPJO was usually detected for signs and symptoms such as abdominal mass, pain, or unexplained urinary symptoms in adult patients [2]. In contrast, the incidental detection of UPJO by the prenatal US is currently the most common mode of presentation in children, who are often asymptomatic at the moment of the diagnosis [3]. This change has resulted in a significant downward shift in the age of pyeloplasty. Open dismembered pyeloplasty, originally described by Anderson and Hynes in 1949, is the most common surgical procedure performed to treat UPJO either in pediatric and adult’s field with a success rate from 90% to 100% [4]. In recent years, minimally invasive surgery (MIS), such as laparoscopy-assisted pyeloplasty (LP) and more recently robot-assisted laparoscopic pyeloplasty (RALP), has emerged as a valid alternative to the open surgery also in younger patients [5,6]. In particular thanks to the 3D imagines and the endowrist technologies RALP offers not only the advantages to be minimally invasive but appeared to be the leader technique to perform upper urinary tract reconstructive surgery [7e9]. If in the initial phase RALP in pediatric field was confined to school-aged children and adolescent (most of the studies describe this subset of population [8e11]), nowadays robotic surgeons have begun to expand its application even in younger infants facing with the challenge of smaller body size and lighter weight [12]. Although other authors have already reported encouraging outcomes of RALP in this new group of patients, setting new limits in terms of age and weight, its feasibility is still debated [13,14]. In this line, this study wants to compare the safety and efficacy of RALP in infants weighing less than 15.0 kg matched with a cohort of children 15.0 kg performed in a referral tertiary center by a single expert surgeon.
Patients and methods Study population We retrospectively reviewed our prospectively collected clinical data to select consecutive patients with UPJO treated with RALP from January 2016 to May 2019 at a single tertiary referral center. We collected and evaluated data from 61 consecutive patients of age under 18 who underwent RALP following the Anderson-Hynes dismembered technique. Patients <1 year old were excluded due to our anesthesiologic protocol and were submitted to open or minilaparoscopic pyeloplasty [15]. All the surgeries were performed by a single expert robotic surgeon who comes from the adult urology field performing robotic procedures since 2010 and with more than 200 cases for a year in the recent period. Eligible for surgery were patients with symptoms and/or typical obstruction aspects at imaging using US. All patients with suspected UPJO were submitted to dynamic renal
L. Masieri et al. scintigraphy that revealed retention of RPh (cumulative renographic curves) after i.v. administration of the diuretic (0.5 mg/kg of Furosemide) at the 20th minute persisted or decreased by less than 50%. After met the inclusion criteria, patients were further classified according to their weight: children who weighed less than 15.0 kg constituted group A and children weighing 15.0 kg or more constituted the control group (group B). Patients characteristics pre-operatively collected were age in months, gender, side of the obstruction, presence of anatomic variants, and crossing vessels. Anterioreposterior diameter of the pelvis (APD) was pre-operatively evaluated. Outcome parameters measured included operative time, length of hospital stay (LOS), reduction of ADP on US, postoperative complications, hospital readmission, and relapse. Total operative time is composed of set-up time and console operative time. Set-up time was defined as the time from skin incision up to the beginning of the surgery at the operative console and included trocar positioning, docking of the robotic system, and skin suturing after completing the procedure. Console operative time was defined as the time spent at the robotic console. The severity of complications was graded according to the modified Clavien classification system [16]. A scheduled follow-up has been conducted at 1 month after stent removal and then at 6 and 12 months in the absence of symptoms. The success was defined as the reduction of hydronephrosis at US and no symptoms. Conversely, patients were classified as failures if (a) their postoperative US demonstrated persistent hydronephrosis with or without symptoms or (b) they had persistent symptoms alone or (c) they required further (endoscopic or surgical) procedures after surgery. To confirm the diagnosis of failures an Isotopic renography was done. All follow-up data were recorded using specific questionnaires and assessed in dedicated ambulatories at our tertiary referral center by medical doctors.
Surgical technique After positioning an 8Ch Foley catheter, the patient was placed in an oblique position and brought to the edge of the table. Gel pillows or pads were used to elevate the side to be treated and to protect pressure points. The ipsilateral arm was positioned near the head, and the patient was secured to the bed across the chest and legs. Trocars were usually placed as far apart as possible to reduce collisions. In detail, first of all, camera trocar (10 mm for Si device and 8 mm for Xi device) was positioned in the umbilicus with a mini-open incision, and pneumoperitoneum was induced with a pressure of 8e10 mmHg according to the patient’s weight; hereafter, the two robotic arms (8 mm for both platforms) were both placed approximately 5e7 cm away from the camera port, in a line perpendicular to an ideal axis passing through the umbilicus and the UPJ, as a sort of ‘kite-like’ appearance (see the picture on the abstract section). Moreover, a slight traction of trocars, tenting the abdominal wall, was strongly useful to create some extra room and have adequate working space. An additional
Please cite this article as: Masieri L et al., Does the body weight influence the outcome in children treated with robotic pyeloplasty?, Journal of Pediatric Urology, https://doi.org/10.1016/j.jpurol.2019.10.023
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Results from robotic pyeloplasty
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Fig. 1 Design of port placement according to kyte-like configuration.
5 mm trocar for the bedside assistant was regularly placed and served for stitches passage, suction, etc. (see Figs. 1 and 2). The robot was docked on the omolateral bedside of the operated kidney in all patients. After mobilization of the hepatic or splenic flexure of the colon, the ureter was identified high in the retroperitoneum and followed toward the pelvis. The transmesocolic window was used only on the left side, when feasible. Gerota’s fascia was opened longitudinally and the ureteropelvic junction was identified, and its surface was cleared to identify any polar crossing vessels. The renal pelvis and the ureter were dissected to ensure a tension-free anastomosis. The renal pelvis around the UPJ was incised and left attached to the upper ureter to serve as a handle and avoid possible injuries on the anastomotic tissues. The ureter was cut and spatulated longitudinally until it was wide enough and the pyeloplasty was performed according to the Anderson-Hynes technique using 6-0 monocryl anterior and posterior running sutures after the first stitch on the ureteral V was positioned similar to our technique reported in the adult [17]. The posterior aspect of the anastomosis was first performed, then a double J stent was inserted and the anterior part was completed. To avoid the emission of the double J stent outside the urethra we filled the bladder in all the patients of group A. According to surgeon preference, abdominal drainage was placed at the end of the procedure; usually, it was placed in case of redo procedure or in case of surgeon perception of the increased complexity of the surgery [18]. In all patients, the ureteral stent has been removed 1 month postoperatively under anesthesia.
Statistical analysis Statistical analysis was performed using SPSS 20.0 (IBM Corporation, Armonk, New York, USA). Categorical, continuous parametric and not-parametric variables were reported as frequencies and proportions, mean and standard deviation, or as median and interquartile range (IQR), respectively. Unpaired t-test, ManneWhitney test, and Pearson’s chi-squared test were used to compare variables, as appropriate. Statistical significance in this study was set as P 0.05.
Fig. 2
Kyte-like port placement.
Results Overall, 61 patients were included in the analysis and are summarized in Table 1. A total of 18 (29%) children constituted group A (weight < 15.0 kg). 8 (44.4%) were male; the median age was 23 months (IQR 13e30), and median weight was 12 kg (IQR 11e13.8; the two extreme weights were 9 and 14 kg). None of them showed anatomical kidney variance. Symptoms have been recorded in 11 (61.1%) cases with flank pain, nausea, and vomiting (Dietl’s crisis) as the most representatives. The median APD measured on US at the moment of diagnosis was 20 mm (IQR 20e32). One patient of 13 months (11 kg) (7.1%) previously received an ipsilateral open pyeloplasty at 2 months. A total of 43 (71%) young patients constituted the control group (group B) with two cases of redo pyeloplasty. 24 (55.8%) were male. The median age was 105 months (IQR 88e154), and the median weight was 33 kg (IQR 28e50; the two extreme weights were 15 and 67 kg). Different anatomical kidney variance was identified in 11 (25.6%) children: 3 (6.9%) duplex collecting system, 4 (9.3%) horseshoe kidneys, 3 (6.9%) abnormal renal rotation, and 1 (2.3%) patient with congenital solitary kidney. The presence of symptoms was recorded in 38 (88.3%) cases with flank pain as the most common, and the difference between the two groups has been found significant (P Z 0.01). In Group B, two patients (4.6%) previously received an ipsilateral open pyeloplasty at 1 and 6 months. The median APD at the diagnosis was 30 mm (range 24e43) with no significant difference between the two groups (P Z 0.45). Peri- and postoperative data are summarized in Table 2. The median (IQR) operative, set-up time and console time were, respectively, 95 (120), 20 (15e25), 75 (70e90) for group A compared to 90 (85e110), 20 (15e25), 73 (65e80) of control group. No significant difference has been found (P > 0.05). No procedures were converted to open or laparoscopic surgery in both groups and only one major complication occurred during hospitalization and it was a case of omental hernia (Clavien 3b) after removal of the drainage requiring surgical correction under general sedation (group A; 5.6%).
Please cite this article as: Masieri L et al., Does the body weight influence the outcome in children treated with robotic pyeloplasty?, Journal of Pediatric Urology, https://doi.org/10.1016/j.jpurol.2019.10.023
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1.e4 Table 1
L. Masieri et al. Pre-operative data of patient.
Pre-operative data Gender, n. %
Male Female Side, n. % Right Left Age (months), median IQR Weight (kg), median IQR Symptoms at diagnosis, n. % Anatomic variant, n. % Crossing vessels, n. % Pre-operative nephrostomy, n. % APD pre-operative, median IQR
kg Z (n; %) kg < 15 (18; 29%)
kg > 15 (43; 71%)
P-value (<0.05)
8 10 6 12 23 12 11 1 3 1
44.4% 55.6% 33.3% 66.7% 13e30 11e13.8 61.1% 5.6% 16.7% 7.1%
24 19 19 24 105 33 38 11 18 2
55.8% 44.2% 44.2% 55.8% 88e154 28e50 88.4% 25.6% 41.9% 5.6%
0.41
0.01 0.73 0.59 0.83
20
20e32
30
24e43
0.45
0.61
APD, anterioreposterior pelvic diameter.
Table 2
Surgical and postoperative data.
Surgical and postoperative data
kg < 15 (18; 29%)
kg > 15 (43; 71%)
P-value (<0.05)
Overall operative time, median IQR Console time, median IQR Set-up time, median IQR Drainage, n. % Yes No Catheter, median IQR APD postoperative, median IQR LOS, median IQR Follow-up months, median IQR Readmission, n. % Relapse, n. % Complication, n. %
95
90e120
90
85e110
0.92
75 20 10 8 3 12
70e90 15e25 55.6% 44.4% 3e3 9e15
75 20 15 28 3 12
65e80 15e25 34.9% 65.1% 3e3 10e15
0.34 0.45 0.13
4 23
3e4 9e27
4 23
3e4 9e33
0.66 0.97
1 1 1
5.6% 5.6% 5.6%
1 1 2
2.3% 2.3% 4.7%
0.51 0.51 0.88
0.92 0.91
APD, anterioreposterior pelvic diameter; LOS, length of stay.
In group B, two (4.7%) patients showed postoperative urinary tract febrile infection successfully treated with broad-spectrum antibiotics (Clavien 2). The median hospital stay was 4 days in both groups (IQR 3e4), and all the patients had the catheter removed in the third postoperative day. At the first month control, after stent removal, a renal US was conducted and revealed a decrease of hydronephrosis in all patients but one belonging to group A. The median (IQR) postoperative APD was 12 mm for both groups (9e15 in group A; 10e15 in group B) with no significant difference found (P Z 0.66). At a median follow-up of 23 months (IQR 9e23 for group A and 9e33 for group B), the success rate was comparable between the two groups (94.4% vs 97.7%; P Z 0.51). Relapse was recorded in one (5.6%) child in group A, who prior received an open pyeloplasty (redo pyeloplasty), presenting persistent hydronephrosis (ADP Z 28 mm) and in one (2.3%) child in group B. Both required nephrostomy placement.
Discussion Although most prenatally diagnosed hydronephroses resolve spontaneously, a subset of patients (10%) presents persistent UPJO requiring surgical intervention [1]. Since the initial report in 1995, this statement has rapidly evolved and now the latest European Association of Urology/European Society for Pediatric Urology guidelines on pediatric urology state that in experienced hands, the success rates (90e95%) of minimally invasive pyeloplasty are similar to the open classical approach [19] in parallel several series focusing on feasibility of robotic surgery in children have been reported. Minnillo et al. in a large single-institution study, assessed outcomes of 155 pediatric patients undergoing RALP and found a success rate of 96%, with only 3% of patients requiring reoperation for recurrent obstruction [20]. Indeed, Silay et al. in a large multicentric experience of
Please cite this article as: Masieri L et al., Does the body weight influence the outcome in children treated with robotic pyeloplasty?, Journal of Pediatric Urology, https://doi.org/10.1016/j.jpurol.2019.10.023
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Results from robotic pyeloplasty nearly 600 patients treated with MIS pyeloplasty, reported a success rate of 99.5% and 97.3%, respectively, for RALP and laparoscopic approach [19]. Cundy et al. included in a recent meta-analysis 13 observational studies, while no randomized controlled trials compared the outcomes of RALP, LP, and OP techniques in children [21]. Overall success (improvement or resolution of hydronephrosis) rates were similar in the three groups and >95%, with either an equivalent or shorter LOS in the RALP cohort [22,23]. As well the favorable outcomes of RALP are reported and documented, the surgeons tried to push the limits of RALP toward ever younger and lighter children. Ballouhey et al. reported a large series of robotic surgery divided according to the weight (<15 and >15 kg) that included 35 robotassisted pyeloplasty without need to conversion to open or laparoscopic approach but with a slightly increase operative time [24]. Ganpule et al. attempted to evaluate the peri-operative outcome of MIS pyeloplasty in children less than 20 kg reporting more favorable results in the robotic group (19 patients) for what concerns the operative time and the LOS [25]. Recently, Kawal et al. compared the efficacy of RALP in children with a median weight of 9.9 kg with an older and heavier (median weight 27.1) cohort. The success rate did not significatively change in either group (94.1% in the lighter group and 96.2% in the other group) [14]. Although the study of Kawal represents one of the largest series available on this topic, it shows some limitations that could have potentially influenced the overall success rate including a short follow-up and the presence of some exclusion criteria while our series is composed by all consecutive patients during the study period. In our experience, none of the patients required conversion to open surgery or experienced intra-operative complications and all demonstrated improvement in hydronephrosis with an overall success rate of 98%. Indeed, it must be noted that some authors have reported the safety and feasibility of RALP in <1 year and <10 kg children; however, the evidence is still weak and indication to RALP in these patients seems to be limited [13,26]. Another topic that in the past period limited robotic procedures in small children consisted of trocar placement due to the restricted space that often causes conflicts between arms; some opponents, indeed, argued that this limitation increases significantly the operative time. Ballouhey et al. proposed a recent comparison of children based on weight undergoing robotic urological surgery and found that weight <15 kg was associated with longer set-up times, with similar surgical times and outcomes [24]. Finkelstein et al. proposed that a distance 13 cm between both anterior superior iliac spines and a puboxyphoid distance 15 cm was associated with greater instrument collisions during surgery in infants and suggested these distances as cut-offs when considering robotic surgery in infants [27]. In our experience in both groups we did not find any difference in operative time, set-up time, or intraoperative limitations between the infants weighing <15.0 kg and 15.0 Kg. Si and Xi devices were both employed according to the availability of the operating room and no distinction was made between the two groups. Although Xi system allows a better maneuverability thanks to its 8 mm trocar ports compared to Si device, we believe
1.e5 that the correct bed positioning of the patient and a reproducible trocar placement method (‘kite-like’ configuration) together with the use of a ‘tent effect,’ are sufficient to achieve an adequate working space and to avoid prolonged operative set up and operative times, regardless of patient’s weight and age. However, this study shows some intrinsic limitations. The relatively small numbers of patients in the <15 kg may have underpowered the comparison with heavier patients. Indeed, the procedures were all performed by an experienced robotic surgeon in a tertiary referral center; as such, our results might not be applicable to all surgeon- or center-related scenarios. Moreover, only two patients were <10 kg so that no definitive conclusions on the safety and feasibility of RALP in this cohort of patients can be drawn. Despite these limitations, our study tried to fill the gaps in the evidence on the feasibility of RALP in low-weight children reporting favorable peri-operative and long-term outcomes. In this challenging scenario, the recently introduced da Vinci single-port robot-assisted platform may further increase the benefits of robotic surgery and may also contribute to widening its indications in the pediatric population [12,28].
Conclusion This study demonstrates that robotic surgery is feasible and safe in children weighing less than 15.0 kg and corroborates the ongoing trend toward the increasing adaptation of RALP for the entire pediatric population. A larger study with longer follow-up is necessary to evaluate the surgical and cosmetic outcomes (Summary Figure, Figs. 1 and 2).
Author statements Conflict of interests None.
Funding None.
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Appendix A. Supplementary data Supplementary data to this article can be found online at https://doi.org/10.1016/j.jpurol.2019.10.023.
Please cite this article as: Masieri L et al., Does the body weight influence the outcome in children treated with robotic pyeloplasty?, Journal of Pediatric Urology, https://doi.org/10.1016/j.jpurol.2019.10.023