Pelvi-ureteric Junction Obstruction In Children Research Articles

Laparoscopic pyeloplasty as treatment modality for congenital pelvi-ureteric junction obstruction in children with pelvic kidney: case series

Laparoscopic pyeloplasty as treatment modality for congenital pelvi-ureteric junction obstruction in children with pelvic kidney: case series

Outcome of Dismembered Pyeloplasty in Children with Unilateral Pelviureteric Junction Obstruction: A Retrospective Observational Study

Introduction: Anderson-Hynes (AH) dismembered pyeloplasty is the standard procedure performed for the management of Pelviureteric Junction Obstruction (PUJO). Ultrasonography (USG) and diuretic renography are of great importance for the diagnosis and follow-up of PUJO. Aim: To evaluate the morphological and functional outcomes of open dismembered pyeloplasty in children with unilateral PUJO and to find the correlation between functional and morphological outcomes. Materials and Methods: A retrospective observational study was conducted, assessing the clinical charts of 200 children under 10 years of age with congenital PUJO who underwent open AH dismembered pyeloplasty in the Department of Paediatric Surgery at a teritary teaching Institute, Government medical college, Thiruvananthapuram, Kerala, India from from June 2015 to June 2020. The preoperative radiological assessment included renal USG and diuretic renography for all patients. Morphological and functional surgical outcomes were measured one year after surgery. The morphologic parameters analysed were the Anteroposterior Diameter (APD) of the pelvis and Parenchymal Thickness (PT). The functional outcome was assessed by improvements in Glomerular Filtration Rate (GFR), Split Renal Function (SRF), and drainage curve. Success was defined as improvement in function and morphology in followup USG and renogram after one year of surgery. Paired t-test was applied for statistical analysis using Statistical Package for the Social Sciences (SPSS) software version 23.0. Results: Among the total 200 patients,180 (90%) cases demonstrated improved renal function after pyeloplasty. Among the total 200 cases, males were 120 (60%) and females were 80 (40%). Morphologic outcome improved in 188 out of 200 (94%) cases. The overall outcome was good in 168 out of 200 (84%) patients. The results showed a moderate negative correlation for APD with respect to SRF (r=-0.677, p-value=0.01) and GFR (r=- 0.430, p-value=0.01), whereas a moderate positive correlation was observed between SRF and GFR (r=0.423, p-value=0.01). Conclusion: AH dismembered pyeloplasty is an effective treatment for PUJO in children, not only relieving obstruction but also improving renal function. The present study recommends considering both morphologic and functional parameters to assess the success of the surgery.

Laparoscopic and robot-assisted ureterocalicostomy for treatment of primary and recurrent pelvi-ureteric junction obstruction in children: a multicenter comparative study with laparoscopic and robot-assisted Anderson-Hynes pyeloplasty

PurposeThis multi-institutional study aimed to assess the outcomes of laparoscopic ureterocalicostomy (LUC) and robot-assisted laparoscopic ureterocalicostomy (RALUC) and compare them with laparoscopic pyeloplasty (LP) and robot-assisted laparoscopic pyeloplasty (RALP) in children with pelvi-ureteric junction obstruction (PUJO).MethodsThe data of 130 patients (80 boys), with median age 7.6 years and median weight 33.8 kg, receiving minimally invasive treatment of PUJO over a 6-year period, were retrospectively analyzed. Patients were grouped according to the operative approach: G1 included 15 patients, receiving LUC (n = 9) and RALUC (n = 6), and G2 included 115 patients, receiving LP (n = 30) and RALP (n = 85). Patient characteristics and operative outcomes were compared in both groups.ResultsThe median patient age and weight were significantly higher in G1 than in G2 [p = 0.001]. The median operative time was similar in both groups (157.6 vs 150.1 min) [p = 0.66] whereas the median anastomotic time was shorter in G1 than in G2 (59.5 vs 83.1 min) [p = 0.03]. The surgical success rate was similar in both groups (100% vs 97.4%) [p = 0.33]. Post-operative complications rate was higher in G1 than in G2 (20% vs 6.1%) but all G1 complications were Clavien 2 and did not require re-intervention.ConclusionLUC/RALUC can be considered safe and effective alternative approaches to LP/RALP for PUJO repair and reported excellent outcomes as primary and salvage procedures. Robot-assisted technique was the preferred option to treat most patients with recurrent PUJO in both groups.

Can urinary biomarkers be used in the outcome assessment of pyeloplasty in children?

BackgroundTo compare the urinary biomarkers—beta 2-microglobulin (β2M), monocyte chemotactic peptide-1 (MCP-1), and transforming growth factor-beta (TGF-β1)—in the outcome assessment of children with pelviureteric junction obstruction (PUJO) undergoing pyeloplasty.MethodsA prospective study was conducted on children with PUJO who had pyeloplasty in a tertiary care center from July 2016 to March 2018. Urine samples were obtained from freshly voided urine samples before surgery and after 6 months of pyeloplasty. Ratio between the levels of biomarkers and urinary creatinine before and after surgery were compared.ResultsA total of 72 patients had pyeloplasty during this period. The mean levels of standardized urinary β2M, MCP-1 and TGF-β1 before surgery were 3.94 ± 4.06, 96.63 ± 117.68 and 310.65 ± 423.87, respectively, which was significantly higher than the corresponding values in the postoperative period, obtained after 6 months of surgery; postoperative mean values were 3.12 ± 3.95, 25.28 ± 32.06, 109.95 ± 118.72 (P < 0.001), respectively. Using Wilcoxon signed-rank test, fall of MCP-1 and TGF-β1 was more significant compared to β2M.ConclusionUrinary biomarkers (β2M, MCP-1 and TGF-β) offer an effective way of outcome assessment of pyeloplasty for PUJO in children, especially MCP-1 and TGF-β1.

Searching for the Least Invasive Management of Pelvi-Ureteric Junction Obstruction in Children: A Critical Literature Review of Comparative Outcomes.

Introduction: To review the published evidence on the minimally invasive pyeloplasty techniques available currently with particular emphasis on the comparative data about the various minimally invasive alternatives to treat pelvi-ureteric junction obstruction and gauge if one should be favored under certain circumstances.Materials and Methods: Non-systematic review of literature on open and minimally invasive pyeloplasty including various kinds of laparoscopic procedures, the robotic-assisted laparoscopic pyeloplasty, and endourological procedures.Results: Any particular minimally invasive pyeloplasty procedure seems feasible in experienced hands, irrespective of age including infants. Comparative data suggest that the robotic-assisted procedure has gained wider acceptance mainly because it is ergonomically more suited to surgeon well-being and facilitates advanced skills with dexterity thanks to 7 degrees of freedom. However, costs remain the major drawback of robotic surgery. In young children and infants, instead, open surgery can be performed via a relatively small incision and quicker time frame.Conclusions: The best approach for pyeloplasty is still a matter of debate. The robotic approach has gained increasing acceptance over the last years with major advantages of the surgeon well-being and ergonomics and the ease of suturing. Evidence, however, may favor the use of open surgery in infancy.

A rare case of ureteropelvic junction obstruction by an aberrant renal vessels

Ureteropelvic junction obstruction results in functionally significant impairment of urinary transport from the renal pelvis to ureter, that may because of intrinsic or extrinsic causes. Abberent renal vessels is the most common cause of pelviureteric junction obstruction in children. Aberrant renal vessels one of the most important cause of ureteropelvic junction obstruction present in about 20-40% of individuals.

A modified technique of paraumbilical three-port laparoscopic dismembered pyeloplasty for infants and children.

Common causes of complications of laparoscopic pyeloplasty in children include anastomotic stricture, poor drainage due to high ureteropelvic anastomosis, and torsion of ureter. Herewith, we described our modified technique of paraumbilical three-port laparoscopic dismembered pyeloplasty (PTLDP) to minimize these complications. Data from 62 patients (age: 1-180months, median: 12months) with ureteropelvic junction obstruction (UPJO) who underwent pyeloplasty using our modified technique of PTLDP between February 2014 and September 2014 at our institution were reviewed. The key steps of our modified method involve identifying the lowest point of the renal pelvis and the lateral aspect of the ureter to guarantee a low pelviureteric and correct orientation anastomosis, and using a 4-0 silk for assistant suturing to avoid crushing of the anastomotic tissue. All surgeries were successfully completed without conversion. Three patients required an accessory port for the anastomosis. All the patients achieved complete clinical or radiologic resolution after the operation. The mean operative time was 103.4min, and mean estimated blood loss was 14.4mL. Mean postoperative differential function of affected kidney was 43.0±16.3% (range 24-100%), increased from 39.7±18.0% (range 18-100%), preoperatively (p<0.001). The success rate was 100% at a mean follow-up of 18.3±2.9 (range 13-25) months. Our modified technique of PTLDP is safe and feasible and to allow high success rate for the treatment of pelviureteric junction obstruction in children.

Comparison of intravenous urography and magnetic resonance urography in preoperative evaluation of pelvi-ureteric junction obstruction in children.

Aims:To compare intravenous urography (IVU) and magnetic resonance urography (MRU) in the preoperative evaluation of pelvi-ureteric junction obstruction (PUJO) in children.Materials and Methods:A total of 35 children up to 10 years of age in whom unilateral or bilateral PUJO were suspected on ultrasonography were enrolled in this prospective study. All children underwent IVU and MRU, and the findings were compared.Results:Of the 70 kidneys evaluated, 14 (20%) were not visualized on IVU because of nonexcretion of contrast, whereas all the 70 (100%) kidneys were visualized on MRU. On IVU, nephrogram was not visualized in 66 (94.2%) of the 70 kidneys, whereas MRU showed prompt and homogeneous nephrogram in 68 (97.1%) of the 70 kidneys. No evidence of PUJO was seen in 31 (44.2%) kidneys on both IVU and MRU. IVU showed PUJO in 26 (37.1%) kidneys, whereas MRU showed it in 38 (54.2%) kidneys. MRU detected two duplex systems that were missed on IVU. A focal renal lesion and two incidental extra renal abnormalities were detected on MRU, which were not visualized on IVU.Conclusion:MRU is better than IVU, especially in case of poorly functioning kidneys which are not visualized on IVU. MRU also provides anatomic details of the ureter and vessels with better evaluation of renal parenchyma. It also has an additional advantage of detecting incidental extra renal abnormalities, if present.

The Expression of Gli3 and Teashirt3 in the Stenotic Tissue of Congenital Pelvi-Ureteric Junction Obstruction in Children.

Background: The aim of this study was to determine the expression pattern of Gli3 and Teashirt3 in stenotic segments in children with congenital hydronephrosis due to pelvi-ureteric junction obstruction (PUJO) versus in normal control subjects.Materials and methods: 60 patients and 10 controls were included in this study. Immunohistochemistry, Western blot and real-time PCR were used to investigate into the expression of Gli3 and Teashirt3.Results: Immunohistochemistry identified that Gli3 and Teashirt3 located in the cytoplasm of smooth muscle in normal ureter. However, the expression of Gli3 and Teashirt3 was negative in the PUJO group. Gli3 and Teashirt3 protein and mRNA expression was significantly decreased in PUJO group compared with control group on Western blot and real time PCR.Conclusions: The expression of protein and mRNA of Gli3 and Teashirt3 was significantly decreased in the PUJO group. Gli3 and Teashirt3 protein was mainly located in the cytoplasm of smooth muscle in normal ureter. Gli3 and Teashirt3 might play an important role in the normal development of the ureter. The down-regulated Gli3 and Teashirt3 perhaps participated in the pathogenesis of the congenital hydronephrosis due to PUJO.

Laparoscopic Transposition of Lower Pole Crossing Vessels (Vascular Hitch) in Children with Pelviureteric Junction Obstruction: How to Be Sure of the Success of the Procedure?

To report a series of children with pelviureteric junction obstruction (PUJO) due to lower polar crossing vessels who underwent laparoscopic vascular transposition. In order to confirm the relief of the obstruction and avoid unnecessary additional procedures, we suggest performing an intraoperative measure of the ureteral opening pressure. From January 2007 and January 2014, 11 children underwent laparoscopy to treat well-documented PUJO by polar vessels. In the first 7 cases, children underwent a careful dissection of the polar vessels that were transposed cranially in the pelvis. In the last 4 cases, a percutaneous needle was inserted into the renal pelvis, and the ureteral opening pressure was obtained intraoperatively, before and after the vascular hitch procedure, in 3 cases. No vascular relocation was necessary except in 1 case with a polar vessel unrelated to the obstruction. The laparoscopic procedure was feasible in all cases. Median operative time was 90 minutes without intraoperative complications. In the last 3 cases, a decrease in the renal pelvic pressure was demonstrated just after releasing the ureter from the polar vessels, confirming the extrinsic obstruction. In 1 case, the intraoperative pelvic pressure measurement showed that there was no vascular compression but that obstruction was due to renal rotation. During follow-up (range, 12-96 months) all patients reported resolution of their symptoms, nine children showed a decrease in the hydronephrosis grade, and all but one with poor function had improved drainage on diuretic renography. Intraoperative measurement of ureteral opening pressure may help to confirm that the vascular hitch procedure has relieved the pelvic obstruction, precluding the need for dismembered procedures. We believe that in some doubtful cases, with the addition of intraoperative pelvic pressure measurement, vascular hitch may be considered a safe procedure to treat selected cases of PUJO in children.

Laparoscopic and Laparoscopic Assisted Pyeloplasty for Repair of Pelvi-Ureteric Junction Obstruction in Children

Laparoscopic and Laparoscopic Assisted Pyeloplasty for Repair of Pelvi-Ureteric Junction Obstruction in Children

Meta-analysis of robot-assisted vs conventional laparoscopic and open pyeloplasty in children.

To critically analyse outcomes for robot-assisted pyeloplasty(RAP) vs conventional laparoscopic pyeloplasty (LP) or open pyeloplasty (OP) by systematic review and meta-analysis of published data. Studies published up to December 2013 were identified from multiple literature databases. Only comparative studies investigating RAP vs LP or OP in children were included.Meta-analysis was performed using random-effects modelling.Heterogeneity, subgroup analysis, and quality scoring were assessed. Effect sizes were estimated by pooled odds ratios and weighted mean differences. Primary outcomes investigated were operative success, re-operation, conversions,postoperative complications, and urinary leakage. Secondary outcome measures were estimated blood loss (EBL), length of hospital stay (LOS), operating time (OT), analgesia requirement, and cost. In all, 12 observational studies met inclusion criteria, reporting outcomes of 384 RAP, 131 LP, and 164 OP procedures. No randomised controlled trials were identified. Pooled analyses determined no significant differences between RAP and LP or OP for all primary outcomes. Significant differences in favour of RAP were found for LOS (vs LP and OP). Borderline significant differences in favour of RAP were found for EBL(vs OP). OT was significantly longer for RAP vs OP. Limited evidence indicates lower opiate analgesia requirement for RAP(vs LP and OP), higher total costs for RAP vs OP, and comparable costs for RAP vs LP. Existing evidence shows largely comparable outcomes amongst surgical techniques available to treat pelvi-ureteric junction obstruction in children. RAP may offer shortened LOS, lower analgesia requirement (vs LP and OP), and lower EBL (vs OP); but compared with OP, these gains are at the expense of higher cost and longer OT. Higher quality evidence from prospective observational studies and clinical trials is required, as well as further cost-effectiveness analyses. Not all perceived benefits of RAP are easily amenable to quantitative assessment.

Postoperative Results Following Surgery for PUJO in Children

Not available.DOI: http://dx.doi.org/10.3329/jpsb.v1i1.19466

Anderson-Hynes pyeloplasty with isthmotomy and lateropexy in horseshoe kidneys with pelviureteric junction obstruction in children.

Objective:The objective of this study was to evaluate the results of Anderson-Hynes pyeloplasty with isthmotomy and lateropexy in horseshoe kidney with pelviureteric junction obstruction (PUJO).Materials and Methods:Medical records of patients of horseshoe kidney with PUJO operated in our institute between June 1998 and June 2012 were reviewed. Anderson-Hynes pyeloplasty with isthmotomy and lateropexy was performed in all patients. The surgical outcome was evaluated with emphasis on the changes in degree of hydronephrosis by ultrasonography, renal drainage and function assessed by diuretic renal scans.Results:We studied the records of eight children of horseshoe kidney having unilateral PUJO. Obstruction was caused by a crossing lower-pole vessel in two cases, a high ureteral insertion in three and narrowing of the PUJ in three cases. Post-operative follow-up (median 4.4 years, range 18 months to 10 years) revealed improved renal function and good drainage in all cases. Hydronephrosis disappeared in 3, 4 showed Grade 1 and one showed Grade 2 hydronephrosis. All children are doing well and have no symptoms.Conclusion:Anderson-Hynes pyeloplasty with isthmotomy and lateropexy is a highly effective and safe procedure for treating PUJO in horseshoe kidney in children.

Plasma rennin activity: Early indicator of renal injury in bilateral pelviureteric junction obstruction in children

Objective:The objective of the present study is to analyze the early indicators of renal injury in children with bilateral pelviuretric junction obstruction.Materials and Methods:We investigated 23 children, 46 kidney units who were diagnosed with bilateral pelvi-ureteric junction obstruction (PUJO) and underwent unilateral or bilateral pyeloplasty between January 2001 and December 2011. Ipsilateral kidney biopsy was performed during pyeloplasty. Kidney biopsy results were divided into three categories. Pre-operative investigation included ultrasonography with the Society of Fetal Urology (SFU) grading, plasma rennin activity (PRA) and differential renal function (DRF).Results:Out of 23 children there were 17 (73.9%) boys while 6 (26.1%) girls. Median age at operation was 35.4 months (range: 9-60 months). Unilateral pyeloplasty was performed in 14 (60.8%), simultaneous bilateral pyeloplasty in 2 (8.6%) and sequential bilateral pyeloplasty in 7 (30.4%).Conclusion:In bilateral PUJO where DRF and SFU grading of hydronephrosis did not correctly reflect renal injury, PRA showed a significant relationship with renal histopathologic grade and could be an early indicator of renal injury in bilateral PUJO.

Factors Predicting Improvement of Renal Function After Pyeloplasty in Pediatric Patients: A Prospective Study

We assessed the specific preoperative sonographic and urinary factors that may be important in predicting renal function outcomes after pyeloplasty. We prospectively studied 52 consecutive patients with ureteropelvic junction obstruction who underwent pyeloplasty at our tertiary care center between September 2009 and January 2011. Mean ± 2 SD patient age was 4.26 years (range 3 months to 18 years), and minimum followup was 6 months. Preoperative ultrasound findings recorded were pelvic anteroposterior diameter, pelvic cortical thickness, pelvic volume and pelvic cortical ratio. Spot urine protein-to-creatinine ratio from the renal pelvis and bladder was measured intraoperatively. Based on changes in differential renal function on diuretic renogram, patients were divided into 3 groups. Group 1 had stable differential renal function with less than 5% change, group 2 had improved differential renal function greater than 5% and group 3 had deterioration of differential renal function greater than 5%. Data were analyzed using SPSS®, version 17 with cross-tabulation, nonparametric tests and logistic regression. On ultrasound only anteroposterior diameter (p = 0.018) and pelvic cortical ratio (p = 0.038) were significantly different among the 3 groups. Difference in bladder sample protein-to-creatinine ratio was not significant (p = 0.69), while pelvic urine protein-to-creatinine ratio was significant (p = 0.001). Anteroposterior diameter, pelvic protein-to-creatinine ratio and pelvic cortical ratio were less than 50 mm, 0.5 and 15, respectively, in all patients with improved renal function. Sonographic and urinary biochemical parameters may predict improvement in renal function after pyeloplasty. Pelvic anteroposterior diameter, pelvic cortical ratio and pelvic urine protein-to-creatinine ratio are the most useful parameters.

Laparoscopic dismembered pyeloplasty in a child with a relatively inaccessible intrarenal pelvis

Laparoscopic pyeloplasty is an accepted way of dealing with pelviureteric junction obstruction in children with extrarenal pelvis. However, intrarenal pelvis has been considered a relative contraindication for laparoscopic pyeloplasty. Here, we describe the technique of laparoscopic dismembered pyeloplasty in a child with intrarenal pelvis. The key when one embraces laparoscopic dismembered pyeloplasty is to ensure that outcomes are not compromised. A successful outcome requires a widely patent, well-vascularised anastomosis performed free of tension.

Pelvis/cortex ratio: A sonographic marker of pelvi ureteric junction obstruction in children

ObjectivesThe aim of the study is to document pelvis/cortex ratio (P/C ratio) in children presenting with antenatally detected hydronephrosis and determine whether it could be used as a sonographic marker of Pelvi ureteric junction (PUJ) obstruction.Materials and Methods:All the children presenting with unilateral fetal hydronephrosis (PUJ) between Jan 2007 and March 2008 were included. Ultrasonogram was performed by the same sonologist and P/C ratio was determined by dividing maximum anteroposterior pelvic diameter with maximum cortical thickness.Results:Among a total of 111 children, 87 (78%) improved on conservative management while 24 (22%) required pyeloplasty. The mean (± SD) P/C ratio was 2.7 ± 2.18 in those improved on conservative management while 13.5 ± 1.48 in those who required surgery (P < 0.01). All (22/22) children with P/C ratio of 12 or above required pyeloplasty, while 2/5 with P/C ratio 8-12 and none (0/84) with P/C ratio less than 8 required pyeloplasty (P<0.01).Conclusions:P/C ratio could be used as a marker of PUJ obstruction in children with hydronephrosis.

Antegrade balloon dilatation of pelvi-ureteric junction obstruction in children

Purpose To report our experience and early results in the use of antegrade endoluminal balloon dilatation as a primary treatment of PUJO in children. Material and Methods Prospective study of children undergoing antegrade endoluminal balloon dilatation of primary PUJO at our center since July 2006. Information was collected on patient demographics, clinical presentation, the procedure of balloon dilatation, renal function and ultrasound measurement of renal pelvic antero-posterior diameter pre- and post-operatively. The procedure was performed under fluoroscopic control using the antegrade placement route for catheter (4Fr or 5Fr) and guidewire. A high pressure balloon (2 mm, 3 mm or 4 mm) was then passed over the wire and positioned across the stenosis for dilatation. A double J stent was then inserted for six weeks. Results We performed 14 balloon dilatations on 14 patients. Nine patients were in the infant age group (under 1 year). The mean age was 14.2 months (range 2 months to 7 years); 66% were male and 33% female. Mean follow up was 17 months (range 4 – 26) and 9 of the 14 patients have a minimum follow up period of 16 months. Mean renal pelvic AP diameter reduced from 3.64 cm (range 3.2 – 4.9) to 1.76 cm (range 1.1 – 2.4). Ipsilateral renal excretion (on MAG3 isotope scanning) improved postoperatively in all patients who underwent MAG3 scans postoperatively (9 out of 15 patients). There was one complication of minor contrast extravasation that happened during balloon dilatation. It proved not to be clinically detrimental in the immediate post-op period or on follow-up. Conclusions Antegrade balloon dilatation is a feasible and safe option in the treatment of primary PUJ obstruction in children. The minimally invasive nature of this technique and our encouraging early results leads us to conclude that this method warrants further clinical evaluation as an alternative to open pyeloplasty.

Laparoscopic transposition of lower pole vessels – the ‘vascular hitch’: An alternative to dismembered pyeloplasty for pelvi-ureteric junction obstruction in children

Objective Dismembered pyeloplasty is the traditional technique in the management of ureterovascular pelvi-ureteric junction obstruction (PUJO) in children. Controversy remains regarding the role of lower pole vessels as the sole aetiology for PUJO. Endopyelotomy and concomitant laparoscopic transposition of lower pole vessels for PUJO has been described in adults. We describe our technique of laparoscopic transposition of lower pole vessels in children with PUJO, leaving the PUJ intact. Patients and methods Thirteen patients (seven boys and six girls) with a mean age of 10.2 years (range 7–16 years) underwent laparoscopic transposition of lower pole vessels. Surgery was indicated on the basis of intermittent pain and ultrasound/MAG3 appearance of obstruction with or without reduced function. The technique involved laparoscopic transperitoneal mobilization of the lower pole vessels from the region of the PUJ thereby freeing the junction and transposing them superiorly onto the anterior wall of the pelvis. The main outcome measures were relief of pain and improvement in ultrasound appearance or drainage parameters on a postoperative MAG3 renogram performed within 4–6 weeks of surgery. Results Median operating time was 92 min. All patients were discharged within 36 h of surgery. All patients remain pain free at a median of 6 months (range 3–18 months). Twelve patients showed good drainage on the postoperative MAG3 renogram and improvement in ultrasound appearance. One patient had recurrent symptoms requiring insertion of a JJ stent. She has undergone further laparoscopic exploration. The vessels were in their transposed position and there was a kink at the PUJ which was released. She had a vertical pyelotomy and transverse closure over the JJ stent with good results. Conclusion This technique is simple and requires less operating time. No anastomosis or temporary JJ stent is required. Our early results are very encouraging with no serious complications.