Urinary CalculiNCT06519812
Endoscopic Combined Intrarenal Surgery vs. Percutaneous Nephrolithotomy for Treatment of Staghorn Calculi
A study testing Combined Intrarenal Surgery and percutaneous nephrolithotomy in people with Urinary Calculi, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This is a prospective randomized study to compare endoscopic combined intrarenal surgery and PCNL as modalities of treatment for staghorn stones. In terms of efficacy and safety Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Urinary Calculi
- What is being tested?
- Combined Intrarenal Surgery and percutaneous nephrolithotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 30 Jun 2025
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are more than 18 and less than 65 years old.
- Patients with renal staghorn stones based on imaging modalities (stones occupying the renal pelvis and extending into at least 2 major calyces).
Who cannot join
- Patients with renal insufficiency (serum creatinine > 1.6 mg/dl)
- patients with active urinary tract infection.
- Patients with congenital renal anomalies.
- Morbid obesity (BMI > 35 kg/m2).
- Pregnancy.
- Bleeding Coagulopathy.
- Skeletal deformity
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Al-Azhar University Hospital (New Damietta)
Damietta, 952567
Mohamed shenishan, master, 01152370018 ext. 020, ffd3994@gmail.com
About this study
Official title: Efficacy and Safety of Endoscopic Combined Intrarenal Surgery vs. Percutaneous Nephrolithotomy for Treatment of Staghorn Calculi, A Prospective Randomized Study
This is a prospective randomized study to compare endoscopic combined intrarenal surgery and PCNL as modalities of treatment for staghorn stones. In terms of efficacy and safety
Read the detailed description
This is a prospective randomized study to compare endoscopic combined intrarenal surgery and PCNL as modalities of treatment for staghorn stones. In terms of efficacy and safety The efficacy will be studied at stone-free rate While efficacy will be studied using DMSA scan pre- and post-procedures in addition to the safety of each procedure with regard to intra- and post-operative complications,.
- Conditions
- Urinary Calculi
- Being tested
- Combined Intrarenal Surgery and 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.
Combined Intrarenal Surgery and percutaneous nephrolithotomyProcedure or surgery
A study was conducted to compare endoscopic combined intrarenal surgery and percutaneous nephrolithotomy as modalities of treatment for staghorn stones.
| Study group | Role | What they receive |
|---|---|---|
| • Group I (PCNL group) | Experimental | 50 patients will undergo percutaneous nephrolithotomy (PCNL). Receives: Procedure: Combined Intrarenal Surgery and percutaneous nephrolithotomy |
| Group II (ECIRS group) | Experimental | 50 patients will undergo endoscopic combined intrarenal surgery (ECIRS). Receives: Procedure: Combined Intrarenal Surgery and percutaneous nephrolithotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
stone-free rate
Stone-free is defined as no residual stones on CT-UT or clinically insignificant residual fragments (CIRF) less than 4 mm in diameter.
It will be measured twice, first immediately postoperatively, and then again after 3 months of the procedure.
Measured: 3 months postoperative
Secondary outcomes (1)
Safety of the procedure
Intra and post-operative complications
Measured: intraoperative, early (in the first day postoperative) and late complications (3 months after the surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Jul 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary CalculiStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maher Mohamed Abdelrehem Mohamed, Al-Azhar University
- Investigators
- Maher Abdelrehem Mohamed, Master, Principal investigator, assistant lecturer of urology , Al-Azhar University (Damietta)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519812
- Sponsor's protocol ID
- Urosurg./MD/2023/0008
- Status last verified
- Jul 2024
- First submitted
- 27 Jun 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Endoscopic Combined Intrarenal Surgery vs. Percutaneous Nephrolithotomy for Treatment of Staghorn Calculi, A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT06519812
- Acronym / sponsor ID
- Urosurg./MD/2023/0008
- Conditions
- Urinary Calculi
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 25 Jul 2024 (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.
This is a prospective randomized study to compare endoscopic combined intrarenal surgery and PCNL as modalities of treatment for staghorn stones. In terms of efficacy and safety
Detailed description
This is a prospective randomized study to compare endoscopic combined intrarenal surgery and PCNL as modalities of treatment for staghorn stones. In terms of efficacy and safety The efficacy will be studied at stone-free rate While efficacy will be studied using DMSA scan pre- and post-procedures in addition to the safety of each procedure with regard to intra- and post-operative complications,.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| • Group I (PCNL group) | Experimental | Procedure: Combined Intrarenal Surgery and percutaneous nephrolithotomy50 patients will undergo percutaneous nephrolithotomy (PCNL). |
| Group II (ECIRS group) | Experimental | Procedure: Combined Intrarenal Surgery and percutaneous nephrolithotomy50 patients will undergo endoscopic combined intrarenal surgery (ECIRS). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients are more than 18 and less than 65 years old.
- Patients with renal staghorn stones based on imaging modalities (stones occupying the renal pelvis and extending into at least 2 major calyces).
Key exclusion criteria (7 listed)
- Patients with renal insufficiency (serum creatinine > 1.6 mg/dl)
- patients with active urinary tract infection.
- Patients with congenital renal anomalies.
- Morbid obesity (BMI > 35 kg/m2).
- Pregnancy.
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 |
|---|---|---|
| Combined Intrarenal Surgery and percutaneous nephrolithotomyA study was conducted to compare endoscopic combined intrarenal surgery and percutaneous nephrolithotomy as modalities of treatment for staghorn stones. | Procedure or surgery | Group II (ECIRS group), • Group I (PCNL group) |
Primary outcome
stone-free rate
Time frame: 3 months postoperative
Stone-free is defined as no residual stones on CT-UT or clinically insignificant residual fragments (CIRF) less than 4 mm in diameter. It will be measured twice, first immediately postoperatively, and then again after 3 months of the procedure.
1 secondary outcome
Safety of the procedure
Time frame: intraoperative, early (in the first day postoperative) and late complications (3 months after the surgery).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Maher Abdelrehem Mohamed, Master principal investigator
assistant lecturer of urology , Al-Azhar University (Damietta)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Intrarenal Surgery and percutaneous nephrolithotomy in people with Urinary Calculi, run by Al-Azhar 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 2 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 25 Jul 2024. 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?
Contact Maher Abdelrehem Mohamed, Master (01026816086 ext. 020, maherabdelrehem2690@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stone-free rate (time frame: 3 months postoperative). 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 25 Jul 2024.