Upper Urinary Tract StonesNCT04158570
Role of Nephrolithometric Scoring Systems in Prediction of PCNL Outcomes in Adult
An observational study of Upper Urinary Tract Stones, run by Assiut University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 17 to 75 years
- Conditions the study is for
- Upper Urinary Tract Stones
- What is being tested?
- Percutaneous Nephrolithotomy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Oct 2019to 25 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 75 years
- All sexes
- Child, Adult, Older adult
Study population: no description
Who may be able to join
- Adult Patients with renal stones scheduled for PCNL.
Who cannot join
- uncorrected coaguloapathy
- skeletal deformities affect lithotomy position
- Pregnancy.
- Patients <16yr.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Urology and Nephrology Hospital
Asyut, 71515
ehab abdelwahab desoky, master, +20 100 726 5685, ehab.desouki88@gmail.com
About this study
Official title: Role of Nephrolithometric Scoring Systems in Prediction of Percutaneous Nephrolithotomy Outcomes in Adult
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.
Read the 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).
- Conditions
- Upper Urinary Tract Stones
- Being tested
- Percutaneous Nephrolithotomy
- Medical subject headings
- Urinary Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous NephrolithotomyProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
stone clearance
postoperative stone and CT-KUB will be done to evaluate the presence of stones .
Measured: 1 or 2 day postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start25 Oct 2019
- Primary completion25 Nov 2021 (estimated)
- Study completion25 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Urinary Tract StonesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Abdelwahab Desoky Abdelmoniem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158570
- Sponsor's protocol ID
- renal stones classification
- Status last verified
- Nov 2019
- First submitted
- 1 Nov 2019
- Last updated
- 12 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Nephrolithometric Scoring Systems in Prediction of Percutaneous Nephrolithotomy Outcomes in Adult
- ClinicalTrials.gov ID
- NCT04158570
- Acronym / sponsor ID
- renal stones classification
- Conditions
- Upper Urinary Tract Stones
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 25 Nov 2021 (estimated)
- Study completion
- 25 Nov 2021 (estimated)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 17 to 75 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- no description
Key inclusion criteria (1 listed)
- Adult Patients with renal stones scheduled for PCNL.
Key exclusion criteria (4 listed)
- uncorrected coaguloapathy
- skeletal deformities affect lithotomy position
- Pregnancy.
- Patients <16yr.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous NephrolithotomyApplication 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. | Procedure or surgery | – |
Primary outcome
stone clearance
Time frame: 1 or 2 day postoperatively
postoperative stone and CT-KUB will be done to evaluate the presence of stones .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Urinary Tract Stones, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stone clearance (time frame: 1 or 2 day postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2019.