Clinical trial NCT04158570: Role of Nephrolithometric Scoring Systems in Prediction of PCNL Outcomes in Adult
Official title: Role of Nephrolithometric Scoring Systems in Prediction of Percutaneous Nephrolithotomy Outcomes in Adult
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Upper Urinary Tract Stones
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-11-12
Enrollment: 200
Sex: ALL
Minimum age (years): 17
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: no description

Brief summary: Prospective study is to compare between different nephrolithometric scoring systems in prediction of PCNL outcomes in terms of efficacy , success rate and safety in Adult patients with UUT stones unilateral or bilateral, single or multiple, Pelvic or calyceal, primary or recurrent, both gender attending Assuit Urology \& Nephrology University Hospital.

Detailed description: The incidence of urolithiasis is approximately 5% to 10% in the general population, In an active urologic department, 30% of the surgical working load is known to be related to treatment of renal and ureteral stones (1, 2). Since the original description of stone removal through a percutaneous nephrostomy tract by Fernstrom and Johansson in 1976, percutaneous stone removal has evolved into a highly developed procedure practiced by many urologists (3). Several new techniques and technologies recently have emerged that simplified the procedure, allowed to take on more challenging cases and made it safer and less painful for patients (4).

Nephrolithometric scoring systems have been introduced to overcome limitations for systematic and quantitative assessment of the outcomes of PCNL. Moreover, preoperative patient counselling necessitates the development of an integrated scoring system to assess PCNL complexity for optimal decision-making Nephrolithometric scoring systems include the Guy's Stone Score (5), S.T.O.N. E. (Stone Size, Tract length, Obstruction/hydronephrosis, Number of involved calyces, Essence/Hounsfield units) nephrolithometry scoring system (6), The Clinical Research Office of the Endourology Society (CROES) nomogram (7), and the Seoul National University Renal Stone Complexity (S-ReSC) score (8,9). All these nephrolithometry scoring systems (NLSS) aim for preoperative prediction of stone-free status (SFS) and complications through assessment of the complexity of different cases undergoing PCNL. NLSS do not only consider the imaging criteria of stones and renal anatomy, but also relevant patient characteristics such as body mass index, previous renal surgery, and surgeon experience. The Guy's Stone Score, S.T.O.N.E. nephrolithometry score and CROES nomogram consist of 11 variables, including four shared parameters (stone size, location, number, and staghorn status). Other variables which are considered by these three NLSS are stone density, renal anatomy, tract length, obstruction of renal pelvis, case load/year, prior treatment history, and the presence of spina bifida or spinal injury.

The Guy's Stone score categorises PCNL cases into four grades, increasing in complexity from Grade 1 to Grade 4, depending on patients' past medical history and non-contrast CT (NCCT) (5).

The S.T.O.N.E. nephrolithometry scoring system assesses PCNL complexity by nine different possible scores, ranging from 5 to 13, according to five NCCT-calculated parameters including stone size, tract length, obstruction/ hydronephrosis, number of involved calyces, Essence/ Hounsfield units (6).

the CROES nephrolithometric nomogram predicts treatment success using plain X-ray of the kidneys, ureters and bladder considering the stone burden, count, and location, in addition to case volume and prior stone treatment (7).

The total score to predict the chance of treatment success is the sum of individual scores derived from each predicting variable; the higher the score, the higher the chance of treatment success, while a patient with a low score has a low chance of achieving a SFS (7). On the other hand, the S-ReSC score is calculated by counting the number of sites involved in the renal pelvis and calyces, regardless of stone parameters or renal anatomy. This system assigns a score from 1 to 9 depending mainly on the number of sites involved; the renal pelvis (1), superior and inferior major calyces (2-3), anterior and posterior minor calyces of the superior (4-5), middle (6-7), and inferior calyces (8-9).

Eligibility criteria: Inclusion criteria:

* Adult Patients with renal stones scheduled for PCNL.

Exclusion criteria:

* uncorrected coaguloapathy
* skeletal deformities affect lithotomy position
* Pregnancy.
* Patients \<16yr.

Primary outcomes:
measure: stone clearance
timeFrame: 1 or 2 day postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Urology and Nephrology Hospital
Study officials:
References: