Renal StoneNCT03719456
Prospective Assessment of Procedure-Related and Patient-Reported Outcomes After Retrograde Intrarenal Surgery (RIRS) for Renal Calculi Less Than 20 mm
A study testing Retrograde Intrarenal Surgery in people with Renal Stone, run by Mansoura University at 2 sites in Egypt.
Trial summary
The investigators aim at this study to prospectively assess procedure-related outcomes after RIRS for renal calculi less than 20 mm, including stone free rate (SFR), predictors of successful outcome, complications types/rate, readmission rate and the need of auxiliary procedures. 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
- What is being tested?
- Retrograde Intrarenal Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jan 2017to 1 Feb 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to give informed consent.
- Stone criteria:
- Less than 20 mm.
- Infectious stone.
- Growing stone on follow-up.
- Kidney criteria:
Show all 13Show fewer
- Obstructing stone causing hydronephrosis.
- Solitary kidney or bilateral renal stones.
- Patients criteria:
- Age ≥18 years.
- Symptomatic stone causing pain or hematuria.
- Patient comorbidity omitting other modalities as bleeding diathesis or skeletal deformities.
- Patient preference or patients' social situation concerning profession or amount of travel
Who cannot join
- Inability to give informed consent.
- Stone criteria:
- More than 20 mm.
- Peripheral calyceal asymptomatic stone static in size on follow-up.
- Unsuitable/failure of initial treatment modalities (oral dissolution therapy-SWL) for stones less than 20 mm.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Urology and Nephrology Center
Al Mansurah, DK, 35516
Amr A Elsawy
Al Manşūrah, 35516
About this study
The investigators aim at this study to prospectively assess procedure-related outcomes after RIRS for renal calculi less than 20 mm, including stone free rate (SFR), predictors of successful outcome, complications types/rate, readmission rate and the need of auxiliary procedures. In addition, patient-reported outcomes after this modality of intervention are going to be assessed.
- Conditions
- Renal Stone
- Being tested
- Retrograde Intrarenal Surgery
- Keywords
- Renal stone, Calculi, Retrograde Intrarenal Surgery, Flexible ureteroscope
- Medical subject headings
- Nephrolithiasis, Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrograde Intrarenal SurgeryProcedure or surgery
Also called Flexible ureteroscope
| Study group | Role | What they receive |
|---|---|---|
| Flexible ureteroscope | Experimental | Not described Receives: Procedure: Retrograde Intrarenal Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
stone free rate (SFR)
stone free rate after the procedure
Measured: It will be assessed by non contrast computed tomography for the participants one month after the procedure
Secondary outcomes (6)
Predictors of operative time of the procedure
Predictors of operative time of the procedure
Measured: Immediately after the procedure
- Post-operative complications using modified Dindo-Clavian grading system
- Post-operative complications (Type/rate/predictors) using modified Dindo-Clavian grading system
Measured: within 30 days after the procedure
Intra-operative clinical judgment of the surgeon on stone free status using flouroscopy and visual scanning of pelvicalyceal system and its relation to post-operative NCCT.
- Intra-operative surgeon perspective about procedure outcome and its relation to post-operative NCCT.
Measured: Post operative day 1 after the procedure
- Patient -reported outcomes about post operative pain using visual analogue scale
- Post-operative pain: Postoperative pain will be evaluated in all patients by using visual analogue scale (VAS). The impact of patient-related, stone-related and procedure-related factors.
Measured: within 3 months after the procedure
Patient -reported outcomes about General impression on the procedure using Freiburg Index of patient Satisfaction (FIPS).
Patient -reported outcomes about General impression on the procedure using Freiburg Index of patient Satisfaction (FIPS).
Measured: within 3 months after the procedure
Assessment of patient-reported outcomes using patient-reported outcomes measurements information system (PROMIS)
Procedure impact on improvement in patient-reported outcomes measurements information system (PROMIS): PROMIS is a National Institute of Health (NIH) validated system to assess patient quality of life. The PROMIS survey consists of 43 questions assessing the following categories: anxiety/fear, depression/ sadness, fatigue, pain interference, physical function, and sleep disturbance.
Measured: within 3 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start1 Jan 2017
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
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 Mansoura 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Abdel-Lateif El-Sawy, Mansoura University
- Investigators
- Amr A Elsawy, MD, Principal investigator, Urology and Nephrology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719456
- Sponsor's protocol ID
- AE 2394
- Status last verified
- Nov 2021
- First submitted
- 17 Oct 2018
- Last updated
- 23 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of Procedure-Related and Patient-Reported Outcomes After Retrograde Intrarenal Surgery (RIRS) for Renal Calculi Less Than 20 mm
- ClinicalTrials.gov ID
- NCT03719456
- Acronym / sponsor ID
- AE 2394
- Conditions
- Renal Stone
- Keywords
- Renal stone, Calculi, Retrograde Intrarenal Surgery, Flexible ureteroscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 25 Oct 2018 (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.
The investigators aim at this study to prospectively assess procedure-related outcomes after RIRS for renal calculi less than 20 mm, including stone free rate (SFR), predictors of successful outcome, complications types/rate, readmission rate and the need of auxiliary procedures. In addition, patient-reported outcomes after this modality of intervention are going to be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flexible ureteroscope | Experimental | Procedure: Retrograde Intrarenal Surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Ability to give informed consent.
- Stone criteria:
- Kidney criteria:
- Patients criteria:
Key exclusion criteria (5 listed)
- Inability to give informed consent.
- Stone criteria:
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 Intrarenal SurgeryAlso: Flexible ureteroscope | Procedure or surgery | Flexible ureteroscope |
Primary outcome
stone free rate (SFR)
Time frame: It will be assessed by non contrast computed tomography for the participants one month after the procedure
stone free rate after the procedure
6 secondary outcomes
Predictors of operative time of the procedure
Time frame: Immediately after the procedure
- Post-operative complications using modified Dindo-Clavian grading system
Time frame: within 30 days after the procedure
Intra-operative clinical judgment of the surgeon on stone free status using flouroscopy and visual scanning of pelvicalyceal system and its relation to post-operative NCCT.
Time frame: Post operative day 1 after the procedure
- Patient -reported outcomes about post operative pain using visual analogue scale
Time frame: within 3 months after the procedure
Patient -reported outcomes about General impression on the procedure using Freiburg Index of patient Satisfaction (FIPS).
Time frame: within 3 months after the procedure
Assessment of patient-reported outcomes using patient-reported outcomes measurements information system (PROMIS)
Time frame: within 3 months after the procedure
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 23 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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.
Amr A Elsawy, MD principal investigator
Urology and Nephrology Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retrograde Intrarenal Surgery in people with Renal Stone, run by Mansoura University at 2 sites 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 13 inclusion and 5 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 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 (SFR) (time frame: It will be assessed by non contrast computed tomography for the participants one month after the 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 23 Nov 2021.