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Role of Nephrolithometric Scoring Systems in Prediction of PCNL Outcomes in Adult

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ClinicalTrials.gov Identifier: NCT04158570
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
Ehab Abdelwahab Desoky Abdelmoniem, Assiut University

Tracking Information
First Submitted Date November 1, 2019
First Posted Date November 12, 2019
Last Update Posted Date November 12, 2019
Actual Study Start Date October 25, 2019
Estimated Primary Completion Date November 25, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 7, 2019)
stone clearance [ Time Frame: 1 or 2 day postoperatively ]
postoperative stone and CT-KUB will be done to evaluate the presence of stones .
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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).

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population no description
Condition Upper Urinary Tract Stones
Intervention Procedure: Percutaneous Nephrolithotomy

Application of different stone scoring systems :

  • Guy's scoring system (GSS).
  • Seoul renal stone complexity scoring system (S-ReSC).
  • S.T.O.N.E. nephrolithometry scoring system.
  • CROES Nomogram. These scoring systems will be applied on each patient and correlate the predictive values with the real results to know which one of the above scoring systems better predict the outcomes.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 7, 2019)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 25, 2021
Estimated Primary Completion Date November 25, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria:

  • Adult Patients with renal stones scheduled for PCNL.

Exclusion criteria:

  • uncorrected coaguloapathy
  • skeletal deformities affect lithotomy position
  • Pregnancy.
  • Patients <16yr.
Sex/Gender
Sexes Eligible for Study: All
Ages 17 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT04158570
Other Study ID Numbers renal stones classification
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Ehab Abdelwahab Desoky Abdelmoniem, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date November 2019