Stones, KidneyNCT04825353
Endoscopic Guided PCNL Versus Standard PCNL
A study testing Endoscopic compbined guided PCNL and Standard PCNL in people with Stones, Kidney, run by Benha University at 1 site in Egypt.
Trial summary
currently, percutaneous nephrolithotomy (PCNL) is the standard procedure of choice for management of large renal more than 2 cm. the pivotal step in performing PCNL is creation of proper tract. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stones, Kidney
- What is being tested?
- Endoscopic compbined guided PCNL and Standard PCNL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2019to 1 Nov 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with renal stones diameter of at least 2 cm.
- American Society of Anesthesiology score ≤ 2.
Who cannot join
- patients with renal anomalies.
- transplanted kidney.
- uncorrected coagulopathy.
- active infection.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Banha university hospital
Banhā, Qalyubia Governorate, 13511
About this study
Official title: Endoscopic Combined Intrarenal Surgery for Management of Large Renal Stones: A Randomized Controlled Trial
currently, percutaneous nephrolithotomy (PCNL) is the standard procedure of choice for management of large renal more than 2 cm.
the pivotal step in performing PCNL is creation of proper tract. this step can be done monitored under guidance of different modalities such as fluoroscopy, ultrasonography, endoscopy or combined in ECIRS, tract creation is controlled under endoscopic vision with a flexible ureteroscope .
Read the detailed description
Aim: compare safety and efficacy and adverse events of ECIRS in comparison of standard fluoroscopic guided PCNL.
patients \& methods: Patients will randomly be divided into two equal groups:
Group A: Patient will undergo ECIRS.
Group B: Patient will undergo standard PCNL
- Conditions
- Stones, Kidney
- Being tested
- Endoscopic compbined guided PCNL, Standard PCNL
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic compbined guided PCNLProcedure or surgery
patient undergo stone removal by ECIRS
Standard PCNLProcedure or surgery
patient undergo SPCNL
| Study group | Role | What they receive |
|---|---|---|
| ECIRS-Group | Experimental | Not described Receives: Procedure: Endoscopic compbined guided PCNL |
| SPCNL-GRoup | Active comparator | Not described Receives: Procedure: Standard PCNL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone Free Rate
If their is any residual stones
Measured: 1day after operation.
Stone Free Rate
If their is any residual stones
Measured: 1 months post operative
Stone Free Rate
If their is any residual stones
Measured: 3 months post-operative
Secondary outcomes (2)
operative time
the length of operation
Measured: intra oprative
blood loss
hemoglobin drop
Measured: pre-operative and 1 day post-oprative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start20 Oct 2019
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stones, KidneyStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed El-Shaer, MD, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825353
- Sponsor's protocol ID
- IDIRB2017122601-268
- Status last verified
- Jul 2022
- First submitted
- 25 Mar 2021
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Combined Intrarenal Surgery for Management of Large Renal Stones: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04825353
- Acronym / sponsor ID
- IDIRB2017122601-268
- Conditions
- Stones, Kidney
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 20 Oct 2019 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 1 Apr 2021 (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.
currently, percutaneous nephrolithotomy (PCNL) is the standard procedure of choice for management of large renal more than 2 cm.
the pivotal step in performing PCNL is creation of proper tract. this step can be done monitored under guidance of different modalities such as fluoroscopy, ultrasonography, endoscopy or combined in ECIRS, tract creation is controlled under endoscopic vision with a flexible ureteroscope .
Detailed description
Aim: compare safety and efficacy and adverse events of ECIRS in comparison of standard fluoroscopic guided PCNL.
patients \& methods: Patients will randomly be divided into two equal groups:
Group A: Patient will undergo ECIRS.
Group B: Patient will undergo standard PCNL
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECIRS-Group | Experimental | Procedure: Endoscopic compbined guided PCNL |
| SPCNL-GRoup | Active comparator | Procedure: Standard PCNL |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with renal stones diameter of at least 2 cm.
- American Society of Anesthesiology score ≤ 2.
Key exclusion criteria (4 listed)
- patients with renal anomalies.
- transplanted kidney.
- uncorrected coagulopathy.
- active infection.
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 |
|---|---|---|
| Endoscopic compbined guided PCNLpatient undergo stone removal by ECIRS | Procedure or surgery | ECIRS-Group |
| Standard PCNLpatient undergo SPCNL | Procedure or surgery | SPCNL-GRoup |
Primary outcome
Stone Free Rate
Time frame: 1day after operation.
If their is any residual stones
Stone Free Rate
Time frame: 1 months post operative
If their is any residual stones
Stone Free Rate
Time frame: 3 months post-operative
If their is any residual stones
2 secondary outcomes
operative time
Time frame: intra oprative
blood loss
Time frame: pre-operative and 1 day post-oprative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
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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?
A study testing Endoscopic compbined guided PCNL and Standard PCNL in people with Stones, Kidney, run by Benha 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 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 19 Jul 2022. 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 Waleed El-Shaer, M.D (01015767331 ext. 0020, waleed_elshaer@hotmail.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: 1day after operation.). The study lists 3 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 19 Jul 2022; AzTrials last refreshed its copy on 27 Oct 2026.