Safety of percutaneous renal cryoablation: an international multicentre experience from the EuRECA retrospective percutaneous database.

OBJECTIVE: To investigate the safety profile of percutaneous cryoablation of renal tumours < 7 cm, utilising data extracted from an international multicentre registry. MATERIALS AND METHODS: A retrospective review of all immediate and delayed complications from a multicentre database was performed and was categorised according to the Clavien-Dindo classification. Statistical analysis was performed for both overall complications (all Clavien-Dindo) and major complications (Clavien-Dindo 3 to 5). The following criteria were identified as potential predictive factors for complications: centre number, modality of image guidance, tumour size (≤ 4 cm vs. > 4 cm), number of tumours treated in the same session (1 vs. > 1) and tumour histology. RESULTS: A total of 713 renal tumours underwent ablation in 647 individual sessions. In 596 of the cases, one tumour was treated; in the remaining 51 cases, several tumours were treated per session. Mean lesion size was 2.8 cm. Fifty-four complications (Clavien-Dindo 1 to 5) occurred as a result of the 647 procedures, corresponding to an overall complication rate of 8.3%. The most frequent complication was bleeding (3.2%), with 9 cases (1.4%) requiring subsequent treatment. The rate of major complication was 3.4%. The only statistically significant prognostic factor for a major complication was a tumour size > 4 cm. CONCLUSION: Percutaneous renal cryoablation is associated with a low rate of complications. Tumours measuring more than 4 cm are associated with a higher risk of major complications. KEY POINTS: • Percutaneous kidney cryoablation has a low rate of complications. • Bleeding is the most frequent complication. • A tumour size superior to 4 cm is a predictive factor of major complication.

Patient and disease factors predictive of adverse perioperative outcomes after nephrectomy.

INTRODUCTION: The aim of this study was to determine the patient and disease factors predictive of adverse perioperative outcomes after nephrectomy using the British Association of Urological Surgeons (BAUS) audit database. METHODS: All nephrectomies entered on the BAUS database for the year 2012 were included and ten patient or disease factors were selected for analysis. Logistic regression was used to calculate the area under the receiver operating characteristic curve (AUC) (0.5 = no better than chance, 1.0 = perfect prediction) for each variable and 500 bootstrap samples were used to determine variable selection. RESULTS: Data were captured for 6,031 nephrectomies in 2012. World Health Organization performance status (WHO-PS) (AUC: 0.733) and anaemia (AUC: 0.696) were the most significant predictors of 30-day mortality in univariate analysis. WHO-PS (AUC: 0.626) and anaemia (AUC: 0.590) also predicted complications classified as Clavien-Dindo grades III-V. Anaemia (AUC: 0.722) and clinical T stage (AUC: 0.713) predicted need for transfusion. CONCLUSIONS: Adverse perioperative outcomes after nephrectomy are predicted by clinical presentation with haematuria, poor WHO-PS and higher TNM (tumour, lymph nodes, metastasis) stage. This study used surgeon collected data as opposed to an administrative database, which may have advantages in terms of accuracy and breadth of data fields. These data form a basis for preoperative patient counselling and informed consent for nephrectomy. They can also be used as a standard against which surgeons and hospitals can compare their own results.

Our experience with retroperitoneal and transperitoneal laparoscopic pyeloplasty for pelvi-ureteric junction obstruction.

OBJECTIVE: Laparoscopic dismembered pyeloplasty has been quoted to have equivalent success rates to the traditional open procedure in the treatment of pelvi-ureteric junction obstruction (PUJO). The aim of this study was to report our experience with laparoscopic pyeloplasty. PATIENTS AND METHODS: All patients with PUJO are entered into a database to record patient, operative and post-operative details. Over an eleven-year period, 176 procedures were performed. Eighty-three procedures were dismembered laparoscopic pyeloplasties, of which two retroperitoneal procedures were converted to open. The first 17 procedures were performed via the retroperitoneal approach and the following 66 via the transperitoneal route. Thirty-one procedures were open pyeloplasty. RESULTS: The retroperitoneal group had a mean follow up of 35 (16-66) months. Five patients (33%) developed recurrent symptoms with evidence of obstruction seen on the renogram within 4 months and required further surgery. The transperitoneal group had a mean follow up of 15 (3-38) months. Five patients were classified as failures (mean time to failure 4.6 months) resulting in a success rate of 92% for the transperitoneal route. Both groups had a mean post-operative hospital stay of 3.6 days. Open pyeloplasty at our institution has a success rate of 88% at a mean follow up of 85 months (range 3-260 months) and a mean length of post-operative stay of 6 days. CONCLUSION: Overall our success rate following laparoscopic pyeloplasty is 88%. However, our preferred approach is transperitoneal, which is associated with a success rate of 92%. This is equivalent, if not better than that seen following open pyeloplasty with the additional benefits of reduced hospital stay and time to recovery. There are many possible explanations for this difference in success rates between approaches, however equivalent results are reported in the literature and therefore the learning curve is likely to be the major factor in this series.

Evidence for the use of silver-alloy-coated urethral catheters.

Catheter-associated urinary tract infections (CAUTIs) are a common occurrence and are associated with increased patient morbidity and mortality. In addition, they delay patient discharge from hospital, substantially increase hospital costs and promote the emergence of resistant organisms. Any intervention resulting in a decrease in the incidence of CAUTIs would have a significant impact on patient quality of life and hospital costs. By reviewing the current literature, it can be seen that the use of silver-alloy-coated hydrogel catheters can reduce CAUTIs by up to 45%. Despite reducing CAUTIs in most hospital situations, the greatest reduction is seen in postoperative patients, intensive care unit patients and burns patients.

Cost analysis of flexible ureterorenoscopy.

OBJECTIVE: To assess the costs of flexible ureterorenoscopy. MATERIALS AND METHODS: Data were collected prospectively for 100 cases using a new flexible ureteroscope (DUR8, Circon ACMI, Stamford, USA), including the indications for flexible ureterorenoscopy, use of laser probes, disposable instrumentation, and the cost and timing of ureteroscope repair. RESULTS: Of the 100 procedures 68 were for stone disease, 21 for known or suspected transitional cell carcinoma (TCC), six were diagnostic only and five were for pelvi-ureteric junction obstruction. The ureteroscope was repaired after the 29th and 88th cases. The ability of the ureteroscope to deflect was maintained throughout. At the time of purchase the ureteroscope was listed at pound 15 000 and each repair/exchange currently costs pound 4200, thus the total expenditure on the ureteroscope was pound 23 400. Total expenditure on ancillary equipment was pound 28 727, of which pound 22 927 was on disposables and pound 5800 on 10 laser probes. CONCLUSION: In this series the costs of the ancillary equipment exceeded the purchase and maintenance of the ureteroscope, and we expect this trend to continue in the long term. The advent of more durable ureteroscopes may ultimately reduce the frequency of costly repairs. The cost of disposables should be considered in planning the budget.

A comparison of aspiration and sclerotherapy with laparoscopic de-roofing in the management of symptomatic simple renal cysts.

OBJECTIVES: To present the results of a minimally invasive treatment of symptomatic simple renal cysts, and to propose an algorithm for their management. PATIENTS AND METHODS: Seventeen patients presenting with suspected symptomatic simple renal cysts were referred for trial aspiration; 16 presented with loin pain and one with a flank mass. If the cyst and symptoms recurred after a temporary response, they were managed by re-aspiration with sclerotherapy using 95% ethanol, or by laparoscopic de-roofing of the cyst. RESULTS: Of the 17 patients referred, one failed to respond to aspiration and was excluded from further analysis. Three patients had sustained pain relief from simple aspiration alone, 13 required further treatment for symptom relapse, of whom six had aspiration and sclerotherapy, and seven had laparoscopic de-roofing. After a mean follow-up of 17 months, pain had recurred in all five patients originally presenting with pain and managed by sclerotherapy, and the patient who presented with a painless mass from a large cyst also developed pain after sclerotherapy. In contrast, the subsequent seven patients managed by laparoscopic treatment are pain-free at a mean follow-up of 17.7 months. CONCLUSION: Evaluation including a diagnostic aspiration is essential to diagnose a symptomatic cyst. When treatment is indicated, laparoscopic de-roofing appears to be more effective than sclerotherapy.

Endoluminal ultrasonography before retrograde endopyelotomy: can the results match laparoscopic pyeloplasty?

OBJECTIVE: To present the results of endopyelotomy using endoluminal ultrasonography (EUS) to identify crossing vessels, as the success rates of endopyelotomy are generally lower than pyeloplasty, especially in patients with crossing vessels. PATIENTS AND METHODS: Forty-one consecutive patients who underwent EUS before a planned retrograde endopyelotomy were analysed retrospectively. EUS was used to direct the endopyelotomy incision for patients with crossing vessels. Treatment was considered successful if the patient was asymptomatic and unobstructed or improved on renography. The results were compared to those from 18 patients treated by laparoscopic pyeloplasty, some of whom had undergone EUS. RESULTS: Crossing vessels were identified in 27 of the 41 patients (66%). Primary treatment consisted of endopyelotomy for 26 patients and laparoscopic pyeloplasty for 15. The overall success rate for 24 endopyelotomy patients with an adequate follow-up (mean 19 months) was 71%, with more success in patients with no crossing vessels (11 of 13 (85%) vs six of 11 (55%)). Of the 18 patients treated by laparoscopic pyeloplasty (mean follow-up 15.1 months) 17 were successful. CONCLUSION: The results for endopyelotomy were disappointing in patients with crossing vessels, despite using EUS. The results suggest that patients with crossing vessels should be treated by laparoscopic pyeloplasty. More data are needed to compare endopyelotomy with laparoscopic pyeloplasty in patients with no crossing vessels.

Ureteral stent symptom questionnaire: development and validation of a multidimensional quality of life measure.

PURPOSE: We developed the ureteral stent symptom questionnaire (USSQ), a psychometrically valid measure to evaluate symptoms and impact on quality of life of ureteral stents. MATERIALS AND METHODS: A total of 309 patients were asked to participate during different phases of our study. In phase 1 a structured literature search, 9 patient interviews and studies of 90 patients using existing instruments formed the foundation for the initial draft of our new questionnaire. In phase 2 the USSQ was pilot tested, reviewed by experts and field tested in 40 patients to produce a final 38-item draft. In phase 3 formal validation studies were performed in 55 patients to assess validity, reliability and sensitivity to change. Discriminant validation was performed by administering the questionnaire to 3 groups of patients without stents. RESULTS: The final draft addressed various domains of health (6 sections and 38 items) affected by stents covering urinary symptoms, pain, general health, work performance, sexual matters and additional problems. The validation studies showed the questionnaire to be internally consistent (Cronbach's alpha > 0.7) with good test-retest reliability (Pearson's coefficient > 0.84). The questionnaire demonstrated good construct validity and sensitivity to change shown by significant changes in the score with and after removal of stents. The new USSQ discriminated patients with stents from healthy controls (p < 0.001) and patients with urinary calculi without stents and lower urinary tract symptoms. CONCLUSIONS: Indwelling ureteral stents have a significant impact on health related quality of life. The new USSQ is a valid and reliable instrument that is expected to become a standard outcome measure to evaluate the impact and compare different types of stents.

Indwelling ureteral stents: evaluation of symptoms, quality of life and utility.

PURPOSE: We report the prevalence of symptoms associated with ureteral stents, their impact on health related quality of life and utility analysis based on the validation studies of the new ureteral stent symptom questionnaire (USSQ). MATERIALS AND METHODS: A total of 85 consecutive adult patients with unilateral indwelling ureteral stents who were asked to participate during the validation phases of the USSQ were considered for this analysis. They were asked to complete the USSQ and the EuroQol, a weighted utility instrument, 4 weeks after stent insertion and removal. In addition, 40 patients were asked to complete these questionnaires 1 week after stent insertion to assess the prevalence of symptoms and utility values at different times. RESULTS: Of the 85 patients 62 (73%) with a mean age of 50 years completed the necessary questionnaires. Urinary symptoms and pain that affected work performance and general health were important stent related problems. Of the patients 78% reported bothersome urinary symptoms that included storage symptoms, incontinence and hematuria. More than 80% of patients experienced stent related pain affecting daily activities, 32% reported sexual dysfunction, and 58% reported reduced work capacity and negative economic impact. The mean EuroQol utility values, which indicate patient satisfaction with treatment, were significantly reduced following stent insertion. CONCLUSION: Urinary symptoms and pain associated with indwelling ureteral stents interfere with daily activities and result in reduced quality of life in up to 80% of patients. Stents are associated with negative functional capacity and reduced utility values. The results have implications in terms of routine clinical practice, patient counseling and future stent research.

Flexible ureteroscopes: a user's guide.

OBJECTIVE: To compare, quantitatively and qualitatively, four small-diameter flexible ureteroscopes. MATERIALS AND METHODS: Four flexible ureteroscopes from different manufacturers, i.e. the DUR-8 (ACMI, Southborough, MA, USA), Olympus UPF-3 (Keymed, Southend-on-Sea, UK), Storz 11274AA (Karl Storz GmbH, Tuttlingen, Germany) and the Wolf 9 F (Henke Sass Wolf GmbH, Tuttlingen, Germany), were assessed quantitatively by measuring the active tip deflection and irrigation flow rate with laser fibres (200 micro m, 365 micro m), an electrohydraulic lithotripter (1.9 F) and grasping forceps (3 F) in position. They were then assessed subjectively by two endourologists who scored them, using a visual analogue scale (maximum 10), for insertion, deflection mechanism, manoeuvrability, rigidity, image quality and overall satisfaction. RESULTS: All the endoscopes are < 9 F at the tip, although the length of the smallest diameter (bevelled tip vs section of shaft) was variable. Tip deflection was 87-100% of the manufacturers' specifications and decreased by similar percentages with instruments in the working channel. The irrigation flow rate was comparable for instruments with a 3.6 F working channel (72-88 mL/min with an empty working channel), although much greater for the Wolf, which has a 4 F channel (116 mL/min). Direction and image size were nearly identical, as was the field of view, apart from the Wolf (60 degrees vs 90 degrees ). There was agreement in the user assessment for three instruments, with overall satisfaction scores being Storz (4), ACMI (7.5) and Olympus (8.6), but disagreement in scores for Wolf (1.9 vs 5.3). CONCLUSIONS: Whilst there were considerable similarities in the objective assessment among the instruments, the user assessment showed qualitative variability. Thus it is important to try the different instruments before selecting one. Additional variables to consider include durability, cost and service/warranty, which vary considerably among instruments.

Hand-assisted laparoscopic nephrectomy: complications related to the hand-port site.

OBJECTIVE: To evaluate the early results of hand-assisted radical nephrectomy and nephroureterectomy in our institution. PATIENTS AND METHODS: The records of 13 patients with malignant disease of the kidney who underwent hand-assisted laparoscopic radical nephrectomy and nephroureterectomy were reviewed retrospectively. Clinical outcomes were compared with a series of 16 patients who underwent similar procedures via a standard laparoscopic approach. RESULTS: There were three major hand-port wound complications in those who underwent hand-assisted procedures, while one other patient required conversion because of technical failure of the device. The operative duration, length of hospital stay, estimated blood loss, transfusion rate, analgesic requirement, conversion rates, and minor complications were similar between the hand-assisted and standard laparoscopy groups. CONCLUSION: There was little difference between hand-assisted and standard laparoscopy in operative duration or recovery, but there were problems with wound complications which may be related to the hand-assisted approach. We have consequently abandoned the technique in favour of a standard laparoscopic approach.

Re-auditing a regional lithotripsy service.

OBJECTIVE: To assess, in a repeat audit of a regional lithotripsy service, whether changes implemented after a regional audit in 1994 (which showed disappointing results from shock wave lithotripsy, attributable to both poor patient selection and an inadequate fixed-site lithotripter) have had any effect. PATIENTS AND METHODS: A data-collection sheet was devised to gather information on the site, size and number of stones treated, together with information on the lithotripsy treatment and outcome. Patients selected for the audit were the first 50 new patients treated with lithotripsy at each centre in 1999. As only one hospital has a fixed-site lithotripsy machine, the results of mobile lithotripsy were grouped by machine for analysis. RESULTS: There was an overall improvement in patient selection from the previous audits. Few stones of > 16 mm or < 4 mm were treated. Two units treated more ureteric stones, thought to reflect first the influence of a fixed-site lithotripter, and second a willingness to insert a ureteric stent and await the next mobile lithotripter visit. The stone free rates were all disappointingly low (16.7-26.7%) but the results improved when fragments of < 4 mm were included as "successful" giving an "overall success rate" of 45.9-66.7%. The unit with a fixed-site lithotripter appeared to perform better (two-thirds successful) than the mobile machines (Modulith SLX, 51%; Modulith SLK, 46%). One centre visited by both mobile machines had a success rate of 65% but a high rate of auxiliary procedures (35% vs 16-19% vs the fixed-site). CONCLUSION: Although these results show some improvement in patient selection for our regional lithotripsy service, stone-free and success rates are poorer than those reported elsewhere. This may reflect the modern lithotripsy machines that allow day-case treatment with minimal analgesia, and confirms reports by other authors who encourage a re-examination of success rates of shock wave lithotripsy.

Characterization of urinary symptoms in patients with ureteral stents.

OBJECTIVES: To prospectively assess the prevalence and bother of various urinary tract symptoms caused by indwelling ureteral stents using validated questionnaires. METHODS: The study consisted of 60 patients with unilateral ureteral stents. Of these, 30 patients were asked to complete the International Prostate Symptoms Score questionnaire, with additional questions on dysuria, hematuria, and loin pain. The remaining 30 patients were asked to complete the International Continence Society questionnaire. These patients were also asked to complete frequency volume charts and undergo uroflowmetry studies. The questionnaires were completed with a stent in situ and 6 weeks after its removal. RESULTS: Forty-eight patients (36 men and 12 women, mean age 52.8 years) completed the study. A large proportion (80%) of patients reported one or more urinary symptoms. Analysis of the IPSS data revealed impaired global quality of life owing to these urinary symptoms. The responses to additional questions on dysuria and hematuria showed a statistically significant difference, but most International Prostate Symptoms Score questions did not. The results of the International Continence Society study identified storage symptoms, incontinence (60%), and bladder pain (80%) as important bothersome problems. The results of the frequency volume charts were in agreement with the storage symptoms. CONCLUSIONS: Patients with indwelling ureteral stents have a wide range of urinary symptoms that affect their quality of life. Storage symptoms, bladder pain, and hematuria pose a major bother. None of the existing questionnaires covered the entire range of symptoms. The results are useful in better understanding the urinary symptoms associated with stents and in providing patient counseling.

Laparoscopic lymph node sampling in locally advanced prostate cancer.

OBJECTIVE: To assess the role of laparoscopic lymph node sampling in patients with locally advanced prostate cancer before radical radiotherapy, and to show that the procedure is safe when carried out by urologists with the appropriate training. PATIENTS AND METHODS: Patients were selected prospectively using a combination of prostate-specific antigen (PSA) level, clinical stage and Gleason grade, which predicted a > 20% risk of lymph node metastases. Between October 1998 and March 2001, 50 patients (mean age 65 years, range 54-78) underwent laparoscopic pelvic lymphadenectomy. Age, presenting PSA level, Gleason grade, clinical stage, operative time, length of stay, and any adverse events were recorded. The histology reports were reviewed for the presence of nodal metastases. The selection criteria were compared between the groups with and with no nodal metastases. RESULTS: The mean (range) PSA level of the men was 36.8 (4.4-184) ng/mL and the Gleason grade 6.8 (4-9); 58% had stage T3 disease and 12 patients (24%) had lymph node metastases. There were no statistically significant differences in PSA, Gleason grade or clinical stage between those with positive or negative nodes. The mean operative duration was 110 min, although this decreased from 133 min for the first 10 cases; one case was converted to an open procedure. The median (range) postoperative stay was 1 (1-12) days. There were two major (5%) and seven (17%) minor complications. CONCLUSIONS: This study confirms that laparoscopic lymph nodes can be sampled safely by urologists with experience in laparoscopic surgery. Patients with a significant risk of metastases can be selected preoperatively using a combination of PSA, clinical stage and Gleason grade. Lymph node sampling in this group is necessary, as there is no other method of reliably identifying the subgroup of patients with metastatic disease in which radical conformal radiotherapy cannot be justified.

The development and validation of a patient-information booklet on ureteric stents.

OBJECTIVE: To report a scientific approach incorporating patient preferences towards the development of a patient-information booklet about ureteric stents. PATIENTS AND METHODS: Phase 1 of the study included 35 adult patients with ureteric stents who were surveyed using semi-structured interviews (four patients) and a questionnaire (31 patients) to assess various issues relating to information given to patients about ureteric stents. In addition, published papers were assessed and clinicians' opinions sought. The results formed the basis for a comprehensive patient-information booklet about ureteric stents that incorporated patients' views and preferences. In phase 2, the booklet was tested and formally validated by inviting 30 patients, a panel of 20 urologists and general practitioners, and five stent manufacturers to assess the booklet for adequacy, coverage and readability of the content. RESULTS: Of the 35 patients, 30 (19 men and 11 women, mean age 49 years, range 20-78) participated in the initial survey; 80% of patients reported dissatisfaction about the information they received. Patients wanted more information about the use, adverse events and effects of stents on daily life; 85% preferred all relevant information about the stents to be in a written format with illustrative drawings. An eight-page booklet was thus developed. The validation study revealed that the booklet matched patients' experiences (approval score of 9/10, range 8-10) and was reported as satisfactory by clinicians and manufacturers. CONCLUSIONS: A validated information booklet on ureteric stents was developed, incorporating patients' expectations and views. This booklet is expected to be an effective tool for patient communication that would help patients cope better with indwelling stents and be useful in counselling patients. A similar approach could be adopted for the development of other patient-information packs.

Indwelling ureteral stents: evaluation of quality of life to aid outcome analysis.

BACKGROUND: Ureteral stents cause various side effects. We have evaluated health-related quality of life (HRQoL) in patients with stents using validated questionnaires and developed a new stent symptom (intervention)-specific questionnaire (SSQ). PATIENTS AND METHODS: Along with structured literature review and in-depth interviews, prospective sub-studies were carried out using generic (SF-36 [N = 30], EuroQol [N = 40], and Functional Status Questionnaire FSQ [N = 20]) and symptom-specific (IPSS [N = 30] and International Continence Society ICS [N = 30]) questionnaires both with a stent in situ and after removal. The results of these studies formed the foundation for a new SSQ that was pilot tested (N = 10) and field tested (N = 20) in order to develop a final draft of the questionnaire that is formally validated. RESULTS: The qualitative research identified a range of problems. Urinary symptoms, pain, work performance, and general health were the most important. Most patients (80%) experienced bothersome urinary symptoms and stent-related pain. Storage symptoms and incontinence were significant urinary symptoms affecting quality of life. As many as 40% of patients experienced sexual dysfunction. The stent had a significant impact on patients' general health. None of the existing measures evaluated the complete impact. The SSQ includes five sections covering urinary symptoms, pain, sexual matters, general health, and work performance. The preliminary results showed it to be valid, reliable (alpha > 0.7) and responsive to the change in scores (p < 0.05) after stent removal. CONCLUSIONS: Indwelling ureteral stents are associated with significant morbidity, resulting in a reduced HRQoL in 80% of patients. The SSQ is a reliable intervention-specific instrument that would be useful as an outcome measure to evaluate the impact of stents.

Preliminary results of a randomized controlled trial of prophylactic shock wave lithotripsy for small asymptomatic renal calyceal stones.

OBJECTIVE: To report a prospective, randomized study to determine whether prophylactic extracorporeal shockwave lithotripsy (ESWL) is justified as a treatment for small, asymptomatic calyceal stones. PATIENTS AND METHODS: The study included 228 patients with small (< 15 mm total diameter) asymptomatic calyceal stones; 113 patients were randomized to undergo ESWL and 115 to the control group who were kept under observation. Outcome measurements included the stone-free rate, requirement for additional treatment, symptoms, quality of life and renal function. RESULTS: In all, 200 patients had at least one annual follow-up; all outcome measurements reported were those at the most recent follow-up (mean 2.2 years, range 1-5). In the ESWL group 28 patients (28%) were stone-free, compared with 16 (17%) in the observation group (odds ratio 1.95, 95% confidence interval, CI, 0.97-3.89, P = 0.06). Additional treatment in the form of analgesics, antibiotics, ESWL, stent insertion and ureteroscopy, was required in 21 (21%) patients in the observation group and 15 (15%) in the ESWL group (odds ratio 0.66, 95% CI 0.32-1.37, P = 0.27). Ten patients in the observation group required invasive procedures, vs none in the ESWL group. There was no evidence of differences in the symptoms, quality of life or renal function tests between the arms of the trial at the final follow-up. CONCLUSIONS: Prophylactic ESWL for small asymptomatic renal calyceal stones does not appear to offer any advantage to patients in terms of stone-free rate, quality of life, renal function, symptoms or hospital admissions. However, a policy of observation is associated with a greater risk of requiring more invasive procedures. A longer follow-up is required to assess the validity of these preliminary findings.