A Comparative Study of Three Ureteral Stenting Strategies After Ureteroscopic Lithotripsy for Upper Urinary Tract Calculi
In recent years, with the widespread popularization of the enhanced recovery after surgery (ERAS) concept, tubeless ureteroscopic lithotripsy (URL) has gradually become a research hotspot. Multiple studies have indicated that tubeless management may be safe and feasible for strictly selected low-risk patients, and can prevent stent-related complications. Nevertheless, high-quality three-arm controlled trial evidence is still lacking regarding whether complete tubeless management is applicable to all patients with conventional urolithiasis, and whether an optimal time window exists to balance safety and comfort when ureteral stenting is mandatory. Most existing studies only compare stenting versus non-stenting, or long-term versus short-term stenting, without systematic comparison of tubeless management, short-term stenting (1-week indwelling) and conventional stenting (2-week indwelling) within a unified framework.
In summary, although URL techniques have matured, numerous uncertainties remain in postoperative ureteral stent management strategies. Rigorously designed prospective studies are urgently needed in clinical practice to comprehensively evaluate differences in complication control, patient quality of life (assessed by the Ureteral Stent Symptom Questionnaire [USSQ]), unplanned readmission rates and health-economic costs among three management modalities: tubeless approach, stent removal at postoperative 1 week and stent removal at postoperative 2 weeks. This study aims to fill this evidence gap, provide high-level evidence-based medical references for urologists to develop individualized and precise postoperative ureteral stent management protocols, and ultimately achieve dual optimization of patients' recovery speed and quality of life.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Hong He
- Telefonnummer: +8613757118231
- E-Mail: zrhh@zju.edu.cn
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Aged ≥18 years; diagnosed with unilateral upper urinary tract calculi (ureteral calculi or renal pelvic/calyceal calculi, diameter ≤2 cm) by computed tomography (CT) or ultrasonography.
Scheduled for ureteroscopic lithotripsy (URL), including rigid or flexible ureteroscopy.
Exclusion Criteria:
- Patients undergoing bilateral surgery. Pregnant or lactating women. Patients with pre-existing ureteral stents at the time of ureteroscopy. Patients with anatomical abnormalities (e.g., horseshoe kidney, pelvic kidney, solitary kidney) or renal transplant recipients.
Patients with systemic infectious manifestations. Patients unable to provide informed consent. Patients with uncontrolled coagulopathy, severe preoperative hydronephrosis or pyonephrosis.
Patients with incomplete clearance of stone fragments during primary ureteroscopic lithotripsy (URSL).
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Intervention group1
Double-J stent indwelling for 1 week postoperatively
|
Group A (Tubeless Group): No Double-J stent is placed after confirming no severe injury or significant residual calculi upon surgery completion. Postoperative routine anti-inflammatory treatment and fluid infusion are administered. Group B (1-Week Stent Group): A 4.7Fr or 6Fr Double-J stent is indwelled postoperatively. Stent removal is performed via outpatient cystoscopy at postoperative day 7 (±1 day). Group C (2-Week Stent Group): The same type of Double-J stent is indwelled postoperatively. Stent removal is performed via outpatient cystoscopy at postoperative day 14 (±2 days). Standardization: All operations are performed by the same team of senior attending physicians with identical brand laser devices and stents. Perioperative medication regimens are consistent across all groups.
Andere Namen:
|
|
Experimental: Intervention group2
no Double-J stent insertion
|
Group A (Tubeless Group): No Double-J stent is placed after confirming no severe injury or significant residual calculi upon surgery completion. Postoperative routine anti-inflammatory treatment and fluid infusion are administered. Group B (1-Week Stent Group): A 4.7Fr or 6Fr Double-J stent is indwelled postoperatively. Stent removal is performed via outpatient cystoscopy at postoperative day 7 (±1 day). Group C (2-Week Stent Group): The same type of Double-J stent is indwelled postoperatively. Stent removal is performed via outpatient cystoscopy at postoperative day 14 (±2 days). Standardization: All operations are performed by the same team of senior attending physicians with identical brand laser devices and stents. Perioperative medication regimens are consistent across all groups.
Andere Namen:
|
|
Sonstiges: Control group
Double-J stent indwelling for 2 weeks postoperatively
|
Group A (Tubeless Group): No Double-J stent is placed after confirming no severe injury or significant residual calculi upon surgery completion. Postoperative routine anti-inflammatory treatment and fluid infusion are administered. Group B (1-Week Stent Group): A 4.7Fr or 6Fr Double-J stent is indwelled postoperatively. Stent removal is performed via outpatient cystoscopy at postoperative day 7 (±1 day). Group C (2-Week Stent Group): The same type of Double-J stent is indwelled postoperatively. Stent removal is performed via outpatient cystoscopy at postoperative day 14 (±2 days). Standardization: All operations are performed by the same team of senior attending physicians with identical brand laser devices and stents. Perioperative medication regimens are consistent across all groups.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Incidence of postoperative complications
Zeitfenster: 1 month
|
1 month
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 2026-0280
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .