Renal StoneNCT06879990
Retrograde Saline Irrigation During Supine Mini Percutaneous Nephrolithotomy
A study testing Retrograde normal saline irrigation and Without Retrograde normal saline irrigation in people with Renal Stone and Supine Mini Percutaneous Nephrolithotomy, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
This minimally invasive surgery allows us to remove kidney stones through tiny incisions and provides patients with quicker and smoother recoveries Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Stone, Supine Mini Percutaneous Nephrolithotomy
- What is being tested?
- Retrograde normal saline irrigation and Without Retrograde normal saline irrigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 31 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age above 18 years
- renal stones
Who cannot join
- age less than 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Retrograde Saline Irrigation Through Double Lumen Ureteric Catheter During Supine Mini-percutanous Nephrolithotomy for Renal Stones Extraction:a Prospective Controlled Trial
This minimally invasive surgery allows us to remove kidney stones through tiny incisions and provides patients with quicker and smoother recoveries
- Being tested
- Retrograde normal saline irrigation, Without Retrograde normal saline irrigation
- Keywords
- Supine
- Medical subject headings
- Nephrolithiasis, Deception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrograde normal saline irrigationBehavioural
Retrograde normal saline irrigation during supine Mini percutaneous nephrolithotomy
Without Retrograde normal saline irrigationBehavioural
Without Retrograde normal saline irrigation during supine Mini percutaneous nephrolithotomy
| Study group | Role | What they receive |
|---|---|---|
| Supine mini percutaneous nephrolithotomy with irrigation | Experimental | Not described Receives: Behavioral: Retrograde normal saline irrigation |
| Supine mini percutaneous nephrolithotomy without irrigation | Experimental | Not described Receives: Behavioral: Without Retrograde normal saline irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free rate
No stone residual fragments
Measured: two weeks from primary procedure
Secondary outcomes (2)
Assess operative time
Assess operative time in minutes
Measured: During procedure
Post operative complication
Complication may occur post operative like fever , sever pain
Measured: Up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start1 Jan 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
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 Kafrelsheikh 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elsayed Abdelhalim Elsayed, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879990
- Sponsor's protocol ID
- 36264PR17/1/23
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 19 Mar 2025
- 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 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Retrograde Saline Irrigation Through Double Lumen Ureteric Catheter During Supine Mini-percutanous Nephrolithotomy for Renal Stones Extraction:a Prospective Controlled Trial
- ClinicalTrials.gov ID
- NCT06879990
- Acronym / sponsor ID
- 36264PR17/1/23
- Keywords
- Supine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 17 Mar 2025 (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 minimally invasive surgery allows us to remove kidney stones through tiny incisions and provides patients with quicker and smoother recoveries
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supine mini percutaneous nephrolithotomy with irrigation | Experimental | Behavioral: Retrograde normal saline irrigation |
| Supine mini percutaneous nephrolithotomy without irrigation | Experimental | Behavioral: Without Retrograde normal saline irrigation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age above 18 years
- renal stones
Key exclusion criteria (1 listed)
- age less than 18 years
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 |
|---|---|---|
| Retrograde normal saline irrigationRetrograde normal saline irrigation during supine Mini percutaneous nephrolithotomy | Behavioural | Supine mini percutaneous nephrolithotomy with irrigation |
| Without Retrograde normal saline irrigationWithout Retrograde normal saline irrigation during supine Mini percutaneous nephrolithotomy | Behavioural | Supine mini percutaneous nephrolithotomy without irrigation |
Primary outcome
Stone free rate
Time frame: two weeks from primary procedure
No stone residual fragments
2 secondary outcomes
Assess operative time
Time frame: During procedure
Post operative complication
Time frame: Up to 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retrograde normal saline irrigation and Without Retrograde normal saline irrigation in people with Renal Stone and Supine Mini Percutaneous Nephrolithotomy, run by Kafrelsheikh 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 1 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: finished, as of the sponsor's last update on 19 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Stone free rate (time frame: two weeks from primary procedure). 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 Mar 2025.