Renal StoneKUBNCT06185387
Changes Post Percutaneous Nephrolithotomy
An observational study of Renal Stone, run by Assiut University.
Trial summary
Using color doppler U/S, Abdominal U/S and radioisotope to evaluate changes of renal morphology, function and doppler parameters post Percutaneous nephrolithotomy Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Renal Stone
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 May 2025
- How long will I take part?
- 3 Months
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with renal stones that are candidates for PCNL >18 years old
Who may be able to join
- Adult patients with age group ≥ 18 years old with renal stones candidate for PCNL.
Who cannot join
- Patients with any previous intervention to extract the renal stones.
- Patients with malrotated/anomalous kidney.
- Patients with any grade of chronic kidney disease.
- Patients with bleeding diathesis.
- Patients who are unfit for surgery.
- Pregnancy
- Patients who are refusing the participation in our study.
About this study
Official title: Evaluation of Changes of Renal Morphology, Renal Function and Renal Doppler Parameters Post-percutaneous Nephrolithotomy - A Prospective Case Series Study
Using color doppler U/S, Abdominal U/S and radioisotope to evaluate changes of renal morphology, function and doppler parameters post Percutaneous nephrolithotomy
Read the detailed description
Preoperative assessment:
Detailed history: including history of medical comorbidities, previous history of stone disease or previous treatment of renal stones.
Complete physical examination with measurement and documentation of the pre-operative blood pressure for all patients.
Estimation of body mass index (BMI).
Pre-operative laboratory investigations including:
Complete urine analysis Urine culture and sensitivity test Complete blood picture (CBC). Prothrombin time and prothrombin concentration. Serum urea and creatinine Random blood sugar -Pre-operative imaging investigations: Plain KUB( Number, site, size and radio-opacity of Stones) Abdominal ultrasound ( Dimensions, Shape, borders, contour, orientation \& echogenicity, hydronephrosis, stones \& others eg. Cysts) Multi-slice computed tomography (MSCT) abdomen and pelvis without contrast. (Dimensions, Shape, borders, contour, orientation, number, site, size, laterality and density of stones) Color Doppler Ultrasonography ( Renal arteries caliber, outline, resistive index, intrarenal arterial waveforms acceleration time\& peak systolic velocity) Radioisotope scan (DMSA scan)
-Procedural steps and techniques: Patients with urinary tract infections will be treated with the appropriate antibiotics according to urine culture and sensitivity test until negative culture is obtained.
Percutaneous nephrolithotomy (PCNL) will be performed in prone/supine position under general or spinal anesthesia after insertion of a ureteral catheter to the affected site.
Access will be done under fluoroscopic guidance. Tract dilatation will be done by using either balloon dilator or Amplatz teflon dilators then Amplatz will be inserted.
Stone disintegration after well established track will be done by using either pneumatic or ultrasonic or laser lithotripters.
Stone retrieval will be done by either forceps or Zero-tip dormia basket. At the end of the procedure, plastic tube 22 French may be inserted through the Amplatz sheath as nephrostomy tube or not (tubeless).
Intraoperatively: we record operative time, anaesthesia time, site of renal puncture, puncture relation to last rib, dilatation method, teflon dilatation steps, number of accesses, disintegration methods, use of flexible nephroscope, intraoperative blood transfusion, nephrostomy tube, state of nephrostomy tube when open and perioperative complications.
Post-operative care and follow up:
Plain KUB, abdominal ultrasound, CBC, prothrombin time and concentration \& serum creatinine will be done at Day 1 postoperatively.
Measurement of blood pressure at day 1 postoperatively. Abdominal ultrasonography\&Color Doppler Ultrasonography at Day 1, Day 7 and Day 90 postoperatively.
Radioisotope scan (DMSA scan) at day 90 postoperatively. Urine analysis
- Conditions
- Renal Stone
- Medical subject headings
- Nephrolithiasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of renal function post percutaneous nephrolithotomy
Radioisotope scan (DMSA scan) Split function in %
Measured: 3 months
Changes of renal doppler parameters after percutaneous nephrolithotomy.
Measured by Resistive Index
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start1 Mar 2024 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal StoneStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walid Atef Abdulmonem Abdulhafez, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185387
- Sponsor's protocol ID
- Percutaneous*Nephrolithotomy
- Acronym
- KUB
- Status last verified
- Dec 2023
- First submitted
- 12 Nov 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Changes of Renal Morphology, Renal Function and Renal Doppler Parameters Post-percutaneous Nephrolithotomy - A Prospective Case Series Study
- ClinicalTrials.gov ID
- NCT06185387
- Acronym / sponsor ID
- KUB / Percutaneous*Nephrolithotomy
- Conditions
- Renal Stone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 29 Dec 2023 (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.
Using color doppler U/S, Abdominal U/S and radioisotope to evaluate changes of renal morphology, function and doppler parameters post Percutaneous nephrolithotomy
Detailed description
Preoperative assessment:
Detailed history: including history of medical comorbidities, previous history of stone disease or previous treatment of renal stones.
Complete physical examination with measurement and documentation of the pre-operative blood pressure for all patients.
Estimation of body mass index (BMI).
Pre-operative laboratory investigations including:
Complete urine analysis Urine culture and sensitivity test Complete blood picture (CBC). Prothrombin time and prothrombin concentration. Serum urea and creatinine Random blood sugar -Pre-operative imaging investigations: Plain KUB( Number, site, size and radio-opacity of Stones) Abdominal ultrasound ( Dimensions, Shape, borders, contour, orientation \& echogenicity, hydronephrosis, stones \& others eg. Cysts) Multi-slice computed tomography (MSCT) abdomen and pelvis without contrast. (Dimensions, Shape, borders, contour, orientation, number, site, size, laterality and density of stones) Color Doppler Ultrasonography ( Renal arteries caliber, outline, resistive index, intrarenal arterial waveforms acceleration time\& peak systolic velocity) Radioisotope scan (DMSA scan)
-Procedural steps and techniques: Patients with urinary tract infections will be treated with the appropriate antibiotics according to urine culture and sensitivity test until negative culture is obtained.
Percutaneous nephrolithotomy (PCNL) will be performed in prone/supine position under general or spinal anesthesia after insertion of a ureteral catheter to the affected site.
Access will be done under fluoroscopic guidance. Tract dilatation will be done by using either balloon dilator or Amplatz teflon dilators then Amplatz will be inserted.
Stone disintegration after well established track will be done by using either pneumatic or ultrasonic or laser lithotripters.
Stone retrieval will be done by either forceps or Zero-tip dormia basket. At the end of the procedure, plastic tube 22 French may be inserted through the Amplatz sheath as nephrostomy tube or not (tubeless).
Intraoperatively: we record operative time, anaesthesia time, site of renal puncture, puncture relation to last rib, dilatation method, teflon dilatation steps, number of accesses, disintegration methods, use of flexible nephroscope, intraoperative blood transfusion, nephrostomy tube, state of nephrostomy tube when open and perioperative complications.
Post-operative care and follow up:
Plain KUB, abdominal ultrasound, CBC, prothrombin time and concentration \& serum creatinine will be done at Day 1 postoperatively.
Measurement of blood pressure at day 1 postoperatively. Abdominal ultrasonography\&Color Doppler Ultrasonography at Day 1, Day 7 and Day 90 postoperatively.
Radioisotope scan (DMSA scan) at day 90 postoperatively. Urine analysis
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with renal stones that are candidates for PCNL >18 years old
Key inclusion criteria (1 listed)
- Adult patients with age group ≥ 18 years old with renal stones candidate for PCNL.
Key exclusion criteria (7 listed)
- Patients with any previous intervention to extract the renal stones.
- Patients with malrotated/anomalous kidney.
- Patients with any grade of chronic kidney disease.
- Patients with bleeding diathesis.
- Patients who are unfit for surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes of renal function post percutaneous nephrolithotomy
Time frame: 3 months
Radioisotope scan (DMSA scan) Split function in %
Changes of renal doppler parameters after percutaneous nephrolithotomy.
Time frame: 3 months
Measured by Resistive Index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Stone, run by Assiut University.
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 7 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 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of renal function post percutaneous nephrolithotomy (time frame: 3 months). The study lists 2 primary outcomes in all. 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 29 Dec 2023.