Retrograde Intrarenal SurgeryNCT06795256
Homework in Retrograde Intrarenal Surgery
A study testing Percussion and position change in retrograde intrarenal surgery in people with Retrograde Intrarenal Surgery and Stone, Kidney, run by Adiyaman University at 1 site in Turkey (Türkiye).
Trial summary
To evaluate the effectiveness of this homework on stone clearance rates after retrograde intrarenal surgery (RIRS) by instructing the patient in the home environment and suggesting percussion and movement/position changes to assist in spontaneous stone passage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retrograde Intrarenal Surgery, Stone, Kidney
- What is being tested?
- Percussion and position change in retrograde intrarenal surgery
- 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 siteTurkey (Türkiye)
- Study dates
- 21 Jan 2025to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients with an indication for RIRC
Who cannot join
- Patients with anatomic abnormalities such as horseshoe kidney, fragments in the calyx diverticulum, infundibular stenosis, pelvi-ureteral junction obstruction or ureteral stenosis.
- Patients with morbid obesity, uncontrolled hypertension, previous cerebrovascular accident, skeletal deformity such as significant coronary artery disease or symptomatic gastro-esophageal reflux disease.
- Patients with lumbar disc herniation who have undergone spinal surgery and are unable to undergo behavioral therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Adıyaman University
Adıyaman, 02400
ADIYAMAN EDUCATION AND RESEARCH HOSPITAL, +90 416 216 10 15, adiyamaneah1@saglik.gov.tr
About this study
Official title: Homework to Help with Stone Dissolution in Retrograde Intrarenal Surgery
To evaluate the effectiveness of this homework on stone clearance rates after retrograde intrarenal surgery (RIRS) by instructing the patient in the home environment and suggesting percussion and movement/position changes to assist in spontaneous stone passage.
- Conditions
- Retrograde Intrarenal Surgery, Stone, Kidney
- Being tested
- Percussion and position change in retrograde intrarenal surgery
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percussion and position change in retrograde intrarenal surgeryBehavioural
To evaluate the effectiveness of this homework on stone clearance rates after RIRC by giving instructions to the patient in the home environment and suggesting percussion (tapping) and movement/position changes to help spontaneous stone passage.
| Study group | Role | What they receive |
|---|---|---|
| Homework to Help with Stone Dissolution in Retrograde Intrarenal Surgery | Experimental | Not described Receives: Behavioral: Percussion and position change in retrograde intrarenal surgery |
| Standard Retrograde Intrarenal Surgery | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
stone free rates
Measured: 1 month after the intervention/procedure/surgery
Secondary outcomes (1)
Number of Patients with complications and Number of Patients with need for secondary surgery after retrograde intrarenal surgery
Measured: 1 month after the intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start21 Jan 2025
- Primary completion31 Oct 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retrograde Intrarenal SurgeryStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adiyaman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bedreddin Kalyenci, Adiyaman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795256
- Sponsor's protocol ID
- HRÜ/24.21.21
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Homework to Help with Stone Dissolution in Retrograde Intrarenal Surgery
- ClinicalTrials.gov ID
- NCT06795256
- Acronym / sponsor ID
- HRÜ/24.21.21
- Conditions
- Retrograde Intrarenal Surgery, Stone, Kidney
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Adiyaman UniversityUniversity, hospital or other
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 28 Jan 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.
To evaluate the effectiveness of this homework on stone clearance rates after retrograde intrarenal surgery (RIRS) by instructing the patient in the home environment and suggesting percussion and movement/position changes to assist in spontaneous stone passage.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Homework to Help with Stone Dissolution in Retrograde Intrarenal Surgery | Experimental | Behavioral: Percussion and position change in retrograde intrarenal surgery |
| Standard Retrograde Intrarenal Surgery | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with an indication for RIRC
Key exclusion criteria (3 listed)
- Patients with anatomic abnormalities such as horseshoe kidney, fragments in the calyx diverticulum, infundibular stenosis, pelvi-ureteral junction obstruction or ureteral stenosis.
- Patients with morbid obesity, uncontrolled hypertension, previous cerebrovascular accident, skeletal deformity such as significant coronary artery disease or symptomatic gastro-esophageal reflux disease.
- Patients with lumbar disc herniation who have undergone spinal surgery and are unable to undergo behavioral therapy.
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 |
|---|---|---|
| Percussion and position change in retrograde intrarenal surgeryTo evaluate the effectiveness of this homework on stone clearance rates after RIRC by giving instructions to the patient in the home environment and suggesting percussion (tapping) and movement/position changes to help spontaneous stone passage. | Behavioural | Homework to Help with Stone Dissolution in Retrograde Intrarenal Surgery |
Primary outcome
stone free rates
Time frame: 1 month after the intervention/procedure/surgery
1 secondary outcome
Number of Patients with complications and Number of Patients with need for secondary surgery after retrograde intrarenal surgery
Time frame: 1 month after the intervention/procedure/surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: Yes
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The Effect of a Stress Ball Applied Before Retrograde Intrarenal Surgery
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Normal vs Low Tidal Volume Ventilation in Retrograde Intrarenal Surgery
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Supervised Endoscopic Tele-controlled Intelligent Lithotripsy
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Comparison of Suction and Conventional Ureteral Access Sheaths in Kidney Stone Surgery
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percussion and position change in retrograde intrarenal surgery in people with Retrograde Intrarenal Surgery and Stone, Kidney, run by Adiyaman University at 1 site in Turkey (Türkiye).
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 3 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: looking for participants now, as of the sponsor's last update on 29 Jan 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bedreddin Kalyenci, Doctor (+905554859583, bedreddin84@windowslive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stone free rates (time frame: 1 month after the intervention/procedure/surgery). 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 Jan 2025.