Kidney Calculi Clinical Trial
Official title:
Assessment of Flexible Ureteroscopy Residual Fragments
Residual fragments of urinary calculi after flexible ureteroscopy (URF) can cause symptoms and additional surgeries. The assessment of residual fragments by imaging is not standardized. Computed tomography (CT) is the best way for evaluation of urinary stones, however, ionizing radiation from CT is deleterious. The aim of this study is to define which patients may avoid CT for evaluation of residual fragments after URF. 115 patients with > 18 years old undergoing URF for kidney stone < 20 mm or < 15 mm in the lower calyx diagnosed by CT will be studied. The clinical evaluation of patients will be held by the same urologist in pre-operative consultation, 7 days after the procedure, 30 days after the procedure and 100 days after the procedure. The assessment of residual fragments will be made through TC, ultrasound and Kidney-bladder-ureter KUB 90 days after the procedure. The image methods for residual fragments assessment will be compared by Cochran Test and prediction of parameters to avoid CT will be made by multiple logistic regression, using IPSS 16.0, with significant level of 5%.
Flexible ureteroscopy (URF) is being widely used for the treatment of kidney stones up to 20
mm. The assessment of residual fragments must be done because they could cause pain and
additional surgical interventions. However, nor the timing or modality of image study for
this assessment is standardized yet.
Computed Tomography (CT) has become the standard for diagnosing urinary stones. Stone-former
patients are submitted to many CT studies during life due to stone-related events. However,
the cumulative exposure to the ionizing radiation of CT may induce tumors. Therefore,
efforts to reduce radiation exposure are recommended such as better selection of the timing
to submit the patient to CT, low radiation dose protocols and restriction of body region to
be examined.
Up to 38% of the patients have residual fragments more than 2 mm assessed by CT after URF.
The investigators goal is to predict witch patients should be submitted to CT for the
assessment of residual fragments after URF and to evaluate the clinical significance of
residual fragments and URF complications.
Method
115 consecutive symptomatic adult (>18 years-old) patients diagnosed by CT with kidney stone
more than 5 mm and less than 20 mm or less than 15 mm in inferior calyx are going to be
submitted to URF. Residual fragments are going to be assessed by CT, ultrasound and plain
radiography during post-operative period. The study protocol is approved by our hospital's
ethics committee, and written informed consent is going to be obtained from all patients
according to the Declaration of Helsinki Ethical Principles for Medical Research Involving
Human Subjects.
Sample size
Sample size was calculated based on the percentage of patients with residual fragments more
than 2 mm by CT of 38% and by plain radiography of 17%. Therefore, sample size for a
bicaudal test with significance level of 5% and test power of 95% is 115 subjects.
Exclusion factors
Patients with kidney malformations, ureteral stenosis, previous ipsilateral kidney surgery,
hydronephrosis, indwelling double J stent and contraindications for URF are going to be
excluded.
Flexible ureteroscopy
The procedure is going to be performed in a radiation proof operating room under general
anesthesia.
A pyelography is obtained and a Nitinol 0.035" guidewire and a PTFE 0.035" guidewire are
inserted up to the renal pelvis under radioscopy guidance.
Semi-rigid ureteroscopy is performed for active dilation of the ureter. Ureteral sheath
10/12F x 35 cm is than placed up to the upper ureter and the flexible ureteroscope is
inserted through the ureteral sheath for direct identification of all renal calices and
kidney stones before lithotripsy.
Laser lithotripsy will be performed with a 200-270 micron Holmium laser fiber until complete
stone dusting or basketing of stone fragments > 2 mm with < 1.9 F tipless basket. Stone
fragments < 2 mm are acceptable. Pyelography through ureteral sheath will be done to search
for perforation of the urinary tract and to help proper positioning of 6 F double J stent in
the renal pelvis. The ureteral sheath is going to be removed under direct ureteroscopic
vision to care for ureteral lesions and ureteral stone fragments.
Follow-up
The clinical evaluation will be held by the same urologist in pre-operative consultation, 7
days after the procedure, 30 days after the procedure and 100 days after the procedure. The
assessment of residual fragments will bem ade through CT, urinary tract Ultrasound (US) and
X-Ray of the abdomen (Rx) in 90 days postoperatively in all patients. After the procedure,
patients receive guidelines and prescribing for household use standardized pain control.
Evaluated parameters
The parameters evaluated in each patient will be: demographic data like gender, age, race,
body mass index, waist circumference, kidney stone size with 3 measures diameters for
calculation of maximum diameter, area and volume, measured in Hounsfield units of kidney
stone, number of stones, position of the stone in the kidney, kind of ureteroscope used,
operative time measured from the beginning of the cystoscopy to withdrawal of all endoscopic
equipments and from start to finish the insertion of the flexible ureteroscope into the
kidney, lithotripsy technique (basketing without fragmentation, dusting or combined
technique), endoscopic inspection at the end and presence of residual fragments > 2 mm in
postoperative CT, composition of urinary calculi, 2 blood and urinary metabolic evaluations
of each patient to be made between 45 and 90 days of the procedure, including: total
calcium, parathyroid hormone (PTH), uric acid, urea, creatinine, venous blood gas, urine pH,
urine culture, 24 hours urine dosage of calcium, sodium, citrate, oxalate, cystine,
creatinine, urea, uric acid and phosphate. Other authors (8) demonstrated in a retrospective
study that the size of the stone (p < 0.001), location (p< 0.001), multiplicity (p = 0.003),
surgical time (p = 0.008) and exclusive use of flexible ureteroscope (p = 0.029) are
associated with the presence of residual fragments.
Sensitivity and specificity of the combination US + Rx for identification of residual
fragments on postoperative CT, predictive parameters for the best accuracy of the
combination US + Rx and endoscopic end inspection and the occurence of complications such as
ureteral lesion, renal dilatation, visits to the emergency room for pain control, need for
additional procedures are going to be determined.
Statistics
The comparison between the methods of assessment of residual fragments will be done with
Cochran test and prediction of parameters to avoid CT will be made with multiple logistic
regression, using the IPSS 16.0 program, with a significance level of 5%.
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