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

NCT07535281 | Recruiting

• 2 other identifiers: 2025-08-010-0012025-10
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Stones; Nephrolithiasis; Renal Calculi

Keywords

retrograde intrarenal surgery; ureteral access sheath; suction; postoperative pain; infectious complications; renal collecting system

Outcome Measures

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.

  Within 1 hour after arrival in the post-anesthesia care unit (PACU)

Secondary Outcomes (2)

• Postoperative pain intensity as measured by the Numerical Rating Scale (NRS)

  24 ± 4 hours after surgery

• Incidence of infectious complications

  Within 7 days after surgery

Study Arms (2)

Suction-induced collapse group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Complete suction-induced collapse PROCEDURE

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.

Also known as: Suction collapse, Active suctioning through UAS

Suction-induced collapse group

Standard RIRS with natural drainage PROCEDURE

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.

Also known as: Control procedure, Standard drainage

Control group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kangdong Sacred Heart Hospital: lead

Study Sites (1)

Kangdong Sacred Heart Hospital

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

RECRUITING

Related Publications (4)

• Tzelves L, Geraghty R, Juliebo-Jones P, Yuan Y, Kapriniotis K, Castellani D, Gauhar V, Skolarikos A, Somani B. Suction use in ureterorenoscopy: A systematic review and meta-analysis of comparative studies. BJUI Compass. 2024 Jul 8;5(10):895-912. doi: 10.1002/bco2.408. eCollection 2024 Oct.

  PMID: 39416755 BACKGROUND

• Rogers AC, Van De Hoef D, Sahebally SM, Winter DC. A meta-analysis of carbon dioxide versus room air insufflation on patient comfort and key performance indicators at colonoscopy. Int J Colorectal Dis. 2020 Mar;35(3):455-464. doi: 10.1007/s00384-019-03470-4. Epub 2020 Jan 3.

  PMID: 31900583 BACKGROUND

• Khusid JA, Hordines JC, Sadiq AS, Atallah WM, Gupta M. Prevention and Management of Infectious Complications of Retrograde Intrarenal Surgery. Front Surg. 2021 Aug 9;8:718583. doi: 10.3389/fsurg.2021.718583. eCollection 2021.

  PMID: 34434958 BACKGROUND

• Zhang H, Jiang T, Gao R, Chen Q, Chen W, Liu C, Mao H. Risk factors of infectious complications after retrograde intrarenal surgery: a retrospective clinical analysis. J Int Med Res. 2020 Sep;48(9):300060520956833. doi: 10.1177/0300060520956833.

  PMID: 32993406 BACKGROUND

Related Links

• Official Website of Kangdong Sacred Heart Hospital

MeSH Terms

Conditions

Kidney Calculi; Nephrolithiasis; Pain, Postoperative

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Han Kyu Chae, M.D., Ph.D.

  Department of Urology, Kangdong Sacred Heart Hospital, Hallym University College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+821091869125; hanqsinopoli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical associate professor

Model Details: 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.

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 17, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)