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Effect of Complete Suction-Induced Collapse of the Renal Collecting System at the End of RIRS on Early Postoperative Outcomes

ConditionsKidney StonesNephrolithiasisRenal Calculi
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorKangdong Sacred Heart Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Complete suction-induced collapse

    Procedure/Surgery

    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 drainage

    Procedure/Surgery

    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.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Suction-induced collapse groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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
2

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

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Kangdong Sacred Heart HospitalRecruiting05355, Gandong-gu, Outside U.S./CanadaSouth Korea

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kangdong Sacred Heart Hospital

Lead sponsor

Source ClinicalTrials.gov
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