Actively Recruiting

Phase Not Applicable
Age: 20Years - 80Years
All Genders
ID07535281

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

Led by Kangdong Sacred Heart Hospital · Updated on 2026-04-23

90

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating 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 infections in patients with kidney stones. This study compares a suction-induced collapse technique to standard drainage after RIRS to see if this surgical change improves early recovery and patient satisfaction. The trial is a prospective randomized controlled study enrolling 90 patients aged 20 to 80 years. Participants are randomly assigned to one of two groups. The experimental group receives active suctioning through a suction ureteral access sheath (UAS) at the end of RIRS until the renal collecting system collapses visually. The control group undergoes the standard RIRS procedure, where natural drainage is allowed after stopping irrigation without active suction. This comparison aims to assess the benefits of suction-induced collapse over usual care. During the study, patients will be monitored for postoperative flank pain intensity in the recovery room and on the first day after surgery using the Numerical Rating Scale (NRS). Researchers will also track infectious complications such as fever, urinary tract infection, or sepsis within 7 days, along with total analgesic use. The study involves clinical assessments, pain scoring, and safety monitoring to evaluate early postoperative outcomes after RIRS with or without suction-induced collapse.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 20Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 20 to 80 years
  • Diagnosed with kidney stones and scheduled for retrograde intrarenal surgery (RIRS)
  • Have voluntarily signed the written informed consent form
Not Eligible

You will not qualify if you...

  • Participation in another clinical trial within 1 month prior to enrollment
  • Congenital abnormalities of the urinary or reproductive system
  • Presence of a pre-placed ureteral stent 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 deemed inappropriate for participation by the investigator

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Day of surgery

Participants undergo Retrograde Intrarenal Surgery (RIRS) where either active suctioning is applied through a suction ureteral access sheath (UAS) until the renal collecting system is collapsed or standard natural drainage is allowed after surgery.

1 surgery visit (in-person)

Post-operative Follow-up

Duration - 7 days after surgery

Participants are monitored for postoperative flank pain intensity, infectious complications, and analgesic use in the days following surgery.

1 visit within 1 hour after surgery and 1 visit approximately 24 hours after surgery, with monitoring continuing up to 7 days

Trial Site Locations

Total: 1 location

1

Kangdong Sacred Heart Hospital

Gandong-gu, Outside U.S./Canada, South Korea, 05355

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Research Team

H

Han Kyu Chae, M.D., Ph.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

A meta-analysis of carbon dioxide versus room air insufflation on patient comfort and key performance indicators at colonoscopy.

Ailín C Rogers, Dayna Van De Hoef, Shaheel M Sahebally...

https://pubmed.ncbi.nlm.nih.gov/31900583