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

April 20, 2026 updated by: Han Kyu Chae, Kangdong Sacred Heart Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
    • Outside U.S./Canada
      • Gandong-gu, Outside U.S./Canada, South Korea, 05355
        • Recruiting
        • Kangdong Sacred Heart Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Suction-induced collapse group
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
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.
Other Names:
  • Suction collapse
  • Active suctioning through UAS
Active Comparator: Control group
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
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.
Other Names:
  • Control procedure
  • Standard drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative flank pain intensity
Time Frame: 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.
Within 1 hour after arrival in the post-anesthesia care unit (PACU)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain intensity as measured by the Numerical Rating Scale (NRS)
Time Frame: 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.
24 ± 4 hours after surgery
Incidence of infectious complications
Time Frame: Within 7 days after surgery
Includes fever (≥ 38.0°C), urinary tract infection (UTI), or sepsis within 7 days postoperatively.
Within 7 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kangdong Sacred Heart Hospital

Investigators

  • Principal Investigator: Han Kyu Chae, M.D., Ph.D., Department of Urology, Kangdong Sacred Heart Hospital, Hallym University College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

March 30, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-08-010-001
  • 2025-10 (Kangdong Sacred Heart Hospital Fund)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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