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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-10 | Other Grant/Funding Number | Kangdong Sacred Heart Hospital Fund |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 ± 4 hours after surgery |
| Incidence of infectious complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Han Kyu Chae, M.D., Ph.D. | Contact | +821091869125 | hanqsinopoli@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Han Kyu Chae, M.D., Ph.D. | Department of Urology, Kangdong Sacred Heart Hospital, Hallym University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kangdong Sacred Heart Hospital | Recruiting | Gandong-gu | Outside U.S./Canada | 05355 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39416755 | Background | 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. | |
| 31900583 | Background |
| Label | URL |
|---|---|
| Official Website of Kangdong Sacred Heart Hospital | View source |
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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.
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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.
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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.
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| 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. |
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Includes fever (≥ 38.0°C), urinary tract infection (UTI), or sepsis within 7 days postoperatively. |
| Within 7 days after surgery |
| 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. |
| 34434958 | 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. |
| 32993406 | 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. |
| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D053040 | Nephrolithiasis |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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