Trials / Not Yet Recruiting
Not Yet RecruitingNCT07535281
Effect of Complete Suction-Induced Collapse of the Renal Collecting System at the End of RIRS on Early Postoperative Outcomes
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
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- Kangdong Sacred Heart Hospital · Academic / Other
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Not accepted
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. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Complete suction-induced collapse | 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 | Standard RIRS with natural 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. |
Timeline
- Start date
- 2026-04-01
- Primary completion
- 2027-09-01
- Completion
- 2027-09-01
- First posted
- 2026-04-17
- Last updated
- 2026-04-17
Source: ClinicalTrials.gov record NCT07535281. Inclusion in this directory is not an endorsement.