An interventional study of Complete suction-induced collapse and Standard RIRS with natural drainage in Kidney Stones, Nephrolithiasis and Renal Calculi, sponsored by Kangdong Sacred Heart Hospital. Recruiting at 1 site in South Korea. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Kangdong Sacred Heart Hospital · Not applicable, Interventional, and Treatment
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.
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.
509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.
This study's planned enrollment of 90 is close to the median of 86 across 391 interventional studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →Kangdong Sacred Heart Hospital is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Contraindication
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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.
Procedure: Complete suction-induced collapse
Standard RIRS procedure is performed. At the end of the surgery, only natural drainage is allowed after stopping irrigation, without additional active suctioning.
Procedure: Standard RIRS with natural drainage
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.
Also known as: Suction collapse, Active suctioning through UAS
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.
Also known as: Control procedure, Standard drainage
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.
Time frame: Within 1 hour after arrival in the post-anesthesia care unit (PACU)
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.
Time frame: 24 ± 4 hours after surgery
Incidence of infectious complications
Includes fever (≥ 38.0°C), urinary tract infection (UTI), or sepsis within 7 days postoperatively.
Time frame: Within 7 days after surgery
Plan to share: 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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Kangdong Sacred Heart Hospital