Suction to collapse the kidney's collecting system after RIRS (retrograde intrarenal surgery)
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
This trial will test whether actively suctioning the kidney's collecting system at the end of RIRS reduces early postoperative pain and infections for adults having kidney stone removal.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | Kangdong Sacred Heart Hospital Academic / other |
| Locations | 1 site (Gandong-gu, Outside U.S./Canada) |
| Trial ID | NCT07535281 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial compares active suction through a ureteral access sheath to induce collapse of the renal collecting system versus standard passive drainage at the end of RIRS. Ninety adult patients scheduled for RIRS will be randomized to the suction-induced collapse group or the standard drainage group at a single center. The primary outcome is immediate postoperative flank pain measured by the Numerical Rating Scale in the recovery room, with secondary outcomes including pain on postoperative day 1, infectious complications within 7 days, and total analgesic use. The technique is intended to reduce retained irrigation fluid and intrarenal pressure with a simple intraoperative modification performed before leaving the operating room.
Who should consider this trial
Good fit: Adults aged 20–80 with kidney stones who are scheduled for RIRS and can give informed consent, without pre-stenting, uncontrolled infection, solitary kidney, or other exclusion conditions, are ideal candidates.
Not a fit: Patients with a solitary kidney, uncontrolled urinary tract infection, a pre-placed ureteral stent, recent participation in another trial, or other exclusion criteria are unlikely to be eligible and may not benefit from this approach.
Why it matters
Potential benefit: If successful, this simple intraoperative suction technique could lower early postoperative pain and reduce short-term infectious complications after RIRS.
How similar studies have performed: Suction devices and low-pressure techniques have been explored to reduce intrarenal pressure, but randomized data specifically testing suction-induced collapse at the end of RIRS are limited, so this is a relatively novel randomized test.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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. * 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.
Where this trial is running
Gandong-gu, Outside U.S./Canada
- Kangdong Sacred Heart Hospital — Gandong-gu, Outside U.S./Canada, South Korea (Recruiting)
Study contacts
- Principal investigator: Han Kyu Chae, M.D., Ph.D. — Department of Urology, Kangdong Sacred Heart Hospital, Hallym University College of Medicine
- Study coordinator: Han Kyu Chae, M.D., Ph.D.
- Email: hanqsinopoli@gmail.com
- Phone: +821091869125
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.