Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment
Upper Urinary Tract Stones Procedure: Percutaneous Nephrolithotomy

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).

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Role of Nephrolithometric Scoring Systems in Prediction of Percutaneous Nephrolithotomy Outcomes in Adult
Actual Study Start Date : October 25, 2019
Estimated Primary Completion Date : November 25, 2021
Estimated Study Completion Date : November 25, 2021

Intervention Details:
  • 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.


Primary Outcome Measures :
  1. stone clearance [ Time Frame: 1 or 2 day postoperatively ]
    postoperative stone and CT-KUB will be done to evaluate the presence of stones .



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   17 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
no description
Criteria

Inclusion criteria:

  • Adult Patients with renal stones scheduled for PCNL.

Exclusion criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158570


Locations
Layout table for location information
Egypt
Urology and Nephrology Hospital Recruiting
Assiut, Egypt, 71515
Contact: ehab abdelwahab desoky, master    +20 100 726 5685    ehab.desouki88@gmail.com   
Sponsors and Collaborators
Assiut University
Layout table for additonal information
Responsible Party: Ehab Abdelwahab Desoky Abdelmoniem, Dr Ehab EL Desoky urology specialist, Assiut University
ClinicalTrials.gov Identifier: NCT04158570    
Other Study ID Numbers: renal stones classification
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Calculi
Urolithiasis
Urologic Diseases
Calculi
Pathological Conditions, Anatomical