Kidney StonesNCT07535281
Effect of Complete Suction-Induced Collapse of the Renal Collecting System at the End of RIRS on Early Postoperative Outcomes
A study testing Complete suction-induced collapse and Standard RIRS with natural drainage in people with Kidney Stones and Nephrolithiasis, run by Kangdong Sacred Heart Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate whether actively suctioning the renal collecting system to induce a "collapse" state at the end of retrograde intrarenal surgery (RIRS) can reduce postoperative pain and infection in patients with kidney stones. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Kidney Stones, Nephrolithiasis, Renal Calculi
- What is being tested?
- Complete suction-induced collapse and Standard RIRS with natural drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Apr 2026to Sep 2027
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 20 to 80 years.
- Patients diagnosed with kidney stones and scheduled for retrograde intrarenal surgery (RIRS).
- Patients who have voluntarily signed the written informed consent form
Who cannot join
- Participation in another clinical trial (drug or device) within 1 month prior to enrollment.
- Congenital abnormalities of the urinary or reproductive system.
- Presence of a pre-placed ureteral stent (pre-stenting) at the time of surgery.
- Solitary kidney.
- Uncontrolled urinary tract infection.
- History of ureteral reconstruction on the affected side.
Show all 10Show fewer
- Pregnancy.
- Uncorrectable bleeding diathesis or ongoing therapeutic anticoagulation therapy.
- Contraindications to general anesthesia.
- Other conditions that the investigator deems inappropriate for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Kangdong Sacred Heart Hospital
Gandong-gu, Outside U.S./Canada, 05355
Han Kyu Chae, 8201091869125, hanqsinopoli@gmail.com
About this study
Official title: Effect of Complete Suction-Induced Collapse of the Renal Collecting System at the End of Retrograde Intrarenal Surgery on Early Postoperative Outcomes: A Prospective Randomized Study
The purpose of this study is to evaluate whether actively suctioning the renal collecting system to induce a "collapse" state at the end of retrograde intrarenal surgery (RIRS) can reduce postoperative pain and infection in patients with kidney stones. Participants will be randomly assigned to either the experimental group (suction-induced collapse) or the control group (standard drainage). The study aims to determine if this simple surgical modification can improve early recovery outcomes and patient satisfaction.
Read the detailed description
While RIRS is a standard treatment for kidney stones, postoperative flank pain and infectious complications remain significant issues. These complications are often associated with elevated intrarenal pressure and residual irrigation fluid left in the kidney after surgery.
This prospective randomized controlled trial investigates the clinical efficacy of a "suction-induced collapse" technique using a suction ureteral access sheath (UAS). In the experimental group, at the conclusion of RIRS, active suction will be applied through the UAS until the renal collecting system is visually confirmed to be collapsed. In the control group, standard drainage will be allowed after irrigation stops, without active suctioning.
The primary outcome is postoperative flank pain intensity measured by the Numerical Rating Scale (NRS) in the recovery room. Secondary outcomes include pain scores on postoperative day 1, the incidence of infectious complications (fever, UTI, or sepsis) within 7 days, and the total amount of analgesics used. A total of 90 patients will be enrolled to ensure statistical power.
- Conditions
- Kidney Stones, Nephrolithiasis, Renal Calculi
- Being tested
- Complete suction-induced collapse, Standard RIRS with natural drainage
- Keywords
- retrograde intrarenal surgery, ureteral access sheath, suction, postoperative pain, infectious complications, renal collecting system
- Medical subject headings
- Kidney Calculi, Nephrolithiasis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete suction-induced collapseProcedure or surgery
Also called Suction collapse, Active suctioning through UAS
At the end of Retrograde Intrarenal Surgery (RIRS), active suctioning is performed through a suction ureteral access sheath (UAS) until the renal collecting system is visually confirmed to be collapsed.
Standard RIRS with natural drainageProcedure or surgery
Also called Control procedure, Standard drainage
Standard Retrograde Intrarenal Surgery (RIRS) procedure is performed. At the end of the surgery, only natural drainage is allowed after stopping irrigation, without any additional active suctioning.
| Study group | Role | What they receive |
|---|---|---|
| Suction-induced collapse group | Experimental | At the end of Retrograde Intrarenal Surgery (RIRS), active suctioning is performed through a suction ureteral access sheath (UAS) until the renal collecting system is visually confirmed to be collapsed. Receives: Procedure: Complete suction-induced collapse |
| Control group | Active comparator | Standard RIRS procedure is performed. At the end of the surgery, only natural drainage is allowed after stopping irrigation, without additional active suctioning. Receives: Procedure: Standard RIRS with natural drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative flank pain intensity
Pain is assessed using an 11-point Numerical Rating Scale (NRS), where 0 represents no pain and 10 represents the worst possible pain.
Measured: Within 1 hour after arrival in the post-anesthesia care unit (PACU)
Secondary outcomes (2)
Postoperative pain intensity as measured by the Numerical Rating Scale (NRS)
Pain intensity will be assessed using an 11-point Numerical Rating Scale (NRS), where 0 represents "no pain" and 10 represents "the worst possible pain." Higher scores indicate more severe pain.
Measured: 24 ± 4 hours after surgery
Incidence of infectious complications
Includes fever (≥ 38.0°C), urinary tract infection (UTI), or sepsis within 7 days postoperatively.
Measured: Within 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start20 Apr 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Kidney StonesStudies 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
- Model description
- This is a single-center, prospective, 1:1 randomized, parallel-group study. Participants are assigned to either the experimental group (suction-induced collapse) or the control group (standard drainage) at a 1:1 ratio after the stone removal process is completed during RIRS.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kangdong Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Kyu Chae, Kangdong Sacred Heart Hospital
- Investigators
- Han Kyu Chae, M.D., Ph.D., Principal investigator, Department of Urology, Kangdong Sacred Heart Hospital, Hallym University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535281
- Sponsor's protocol ID
- 2025-08-010-001
- Other IDs
- 2025-10
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect the privacy and confidentiality of the study participants, in accordance with the institutional review board's policy and the informed consent provided by the participants.
Publications
Tzelves L, Geraghty R, Juliebo-Jones P, Yuan Y, Kapriniotis K, Castellani D, Gauhar V, Skolarikos A, Somani B. Suction use in ureterorenoscopy: A systematic review and meta-analysis of comparative studies. BJUI Compass. 2024 Jul 8;5(10):895-912. doi: 10.1002/bco2.408. eCollection 2024 Oct.
PubMed 39416755Rogers AC, Van De Hoef D, Sahebally SM, Winter DC. A meta-analysis of carbon dioxide versus room air insufflation on patient comfort and key performance indicators at colonoscopy. Int J Colorectal Dis. 2020 Mar;35(3):455-464. doi: 10.1007/s00384-019-03470-4. Epub 2020 Jan 3.
PubMed 31900583Khusid JA, Hordines JC, Sadiq AS, Atallah WM, Gupta M. Prevention and Management of Infectious Complications of Retrograde Intrarenal Surgery. Front Surg. 2021 Aug 9;8:718583. doi: 10.3389/fsurg.2021.718583. eCollection 2021.
PubMed 34434958Zhang H, Jiang T, Gao R, Chen Q, Chen W, Liu C, Mao H. Risk factors of infectious complications after retrograde intrarenal surgery: a retrospective clinical analysis. J Int Med Res. 2020 Sep;48(9):300060520956833. doi: 10.1177/0300060520956833.
PubMed 32993406
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Complete Suction-Induced Collapse of the Renal Collecting System at the End of Retrograde Intrarenal Surgery on Early Postoperative Outcomes: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07535281
- Acronym / sponsor ID
- 2025-08-010-001
- Conditions
- Kidney Stones, Nephrolithiasis, Renal Calculi
- Keywords
- retrograde intrarenal surgery, ureteral access sheath, suction, postoperative pain, infectious complications, renal collecting system
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Kangdong Sacred Heart HospitalUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 17 Apr 2026 (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 purpose of this study is to evaluate whether actively suctioning the renal collecting system to induce a "collapse" state at the end of retrograde intrarenal surgery (RIRS) can reduce postoperative pain and infection in patients with kidney stones. Participants will be randomly assigned to either the experimental group (suction-induced collapse) or the control group (standard drainage). The study aims to determine if this simple surgical modification can improve early recovery outcomes and patient satisfaction.
Detailed description
While RIRS is a standard treatment for kidney stones, postoperative flank pain and infectious complications remain significant issues. These complications are often associated with elevated intrarenal pressure and residual irrigation fluid left in the kidney after surgery.
This prospective randomized controlled trial investigates the clinical efficacy of a "suction-induced collapse" technique using a suction ureteral access sheath (UAS). In the experimental group, at the conclusion of RIRS, active suction will be applied through the UAS until the renal collecting system is visually confirmed to be collapsed. In the control group, standard drainage will be allowed after irrigation stops, without active suctioning.
The primary outcome is postoperative flank pain intensity measured by the Numerical Rating Scale (NRS) in the recovery room. Secondary outcomes include pain scores on postoperative day 1, the incidence of infectious complications (fever, UTI, or sepsis) within 7 days, and the total amount of analgesics used. A total of 90 patients will be enrolled to ensure statistical power.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a single-center, prospective, 1:1 randomized, parallel-group study. Participants are assigned to either the experimental group (suction-induced collapse) or the control group (standard drainage) at a 1:1 ratio after the stone removal process is completed during RIRS.
| Arm | Type | Receives |
|---|---|---|
| Suction-induced collapse group | Experimental | Procedure: Complete suction-induced collapseAt the end of Retrograde Intrarenal Surgery (RIRS), active suctioning is performed through a suction ureteral access sheath (UAS) until the renal collecting system is visually confirmed to be collapsed. |
| Control group | Active comparator | Procedure: Standard RIRS with natural drainageStandard RIRS procedure is performed. At the end of the surgery, only natural drainage is allowed after stopping irrigation, without additional active suctioning. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 20 to 80 years.
- Patients diagnosed with kidney stones and scheduled for retrograde intrarenal surgery (RIRS).
- Patients who have voluntarily signed the written informed consent form
Key exclusion criteria (10 listed)
- Participation in another clinical trial (drug or device) within 1 month prior to enrollment.
- Congenital abnormalities of the urinary or reproductive system.
- Presence of a pre-placed ureteral stent (pre-stenting) at the time of surgery.
- Solitary kidney.
- Uncontrolled urinary tract 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 |
|---|---|---|
| Complete suction-induced collapseAlso: Suction collapse, Active suctioning through UASAt the end of Retrograde Intrarenal Surgery (RIRS), active suctioning is performed through a suction ureteral access sheath (UAS) until the renal collecting system is visually confirmed to be collapsed. | Procedure or surgery | Suction-induced collapse group |
| Standard RIRS with natural drainageAlso: Control procedure, Standard drainageStandard Retrograde Intrarenal Surgery (RIRS) procedure is performed. At the end of the surgery, only natural drainage is allowed after stopping irrigation, without any additional active suctioning. | Procedure or surgery | Control group |
Primary outcome
Postoperative flank pain intensity
Time frame: Within 1 hour after arrival in the post-anesthesia care unit (PACU)
Pain is assessed using an 11-point Numerical Rating Scale (NRS), where 0 represents no pain and 10 represents the worst possible pain.
2 secondary outcomes
Postoperative pain intensity as measured by the Numerical Rating Scale (NRS)
Time frame: 24 ± 4 hours after surgery
Incidence of infectious complications
Time frame: Within 7 days after 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 23 Apr 2026.
- Background: PubMed 39416755Tzelves L, Geraghty R, Juliebo-Jones P, Yuan Y, Kapriniotis K, Castellani D, Gauhar V, Skolarikos A, Somani B. Suction use in ureterorenoscopy: A systematic review and meta-analysis of comparative studies. BJUI Compass. 2024 Jul 8;5(10):895-912. doi: 10.1002/bco2.408. eCollection 2024 Oct.
- Background: PubMed 31900583Rogers AC, Van De Hoef D, Sahebally SM, Winter DC. A meta-analysis of carbon dioxide versus room air insufflation on patient comfort and key performance indicators at colonoscopy. Int J Colorectal Dis. 2020 Mar;35(3):455-464. doi: 10.1007/s00384-019-03470-4. Epub 2020 Jan 3.
- Background: PubMed 34434958Khusid JA, Hordines JC, Sadiq AS, Atallah WM, Gupta M. Prevention and Management of Infectious Complications of Retrograde Intrarenal Surgery. Front Surg. 2021 Aug 9;8:718583. doi: 10.3389/fsurg.2021.718583. eCollection 2021.
- Background: PubMed 32993406Zhang H, Jiang T, Gao R, Chen Q, Chen W, Liu C, Mao H. Risk factors of infectious complications after retrograde intrarenal surgery: a retrospective clinical analysis. J Int Med Res. 2020 Sep;48(9):300060520956833. doi: 10.1177/0300060520956833.
- Official Website of Kangdong Sacred Heart HospitalLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect the privacy and confidentiality of the study participants, in accordance with the institutional review board's policy and the informed consent provided by the participants.
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Kidney Stones
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.
Han Kyu Chae, M.D., Ph.D. principal investigator
Department of Urology, Kangdong Sacred Heart Hospital, Hallym University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complete suction-induced collapse and Standard RIRS with natural drainage in people with Kidney Stones and Nephrolithiasis, run by Kangdong Sacred Heart Hospital at 1 site in South Korea.
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 3 inclusion and 10 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 23 Apr 2026. 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 South Korea. 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 Han Kyu Chae, M.D., Ph.D. (+821091869125, hanqsinopoli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative flank pain intensity (time frame: Within 1 hour after arrival in the post-anesthesia care unit (PACU)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07535281, which also lists 4 linked publications.
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 Apr 2026.