Kidney Stones, Nephrolithiasis, Renal Calculi
Conditions
Keywords
retrograde intrarenal surgery, ureteral access sheath, suction, postoperative pain, infectious complications, renal collecting system
Brief 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.
Interventions
PROCEDUREComplete 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.
PROCEDUREStandard 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.
Sponsors
Kangdong Sacred Heart Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
This is a single-blind study in which participants are unaware of their group assignment. Additionally, to ensure objective evaluation, the clinical staff (nurses) in the recovery room (PACU) who measure and record the primary outcome (NRS pain score) are blinded to the participants' treatment groups.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative flank pain intensity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain intensity as measured by the Numerical Rating Scale (NRS) | 24 ± 4 hours after surgery | 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. |
| Incidence of infectious complications | Within 7 days after surgery | Includes fever (≥ 38.0°C), urinary tract infection (UTI), or sepsis within 7 days postoperatively. |
Countries
South Korea
Contacts
CONTACTHan Kyu Chae, M.D., Ph.D.
PRINCIPAL_INVESTIGATORHan Kyu Chae, M.D., Ph.D.
Department of Urology, Kangdong Sacred Heart Hospital, Hallym University College of Medicine
Outcome results
None listed