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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Hong He
- Telefonní číslo: +8613757118231
- E-mail: zrhh@zju.edu.cn
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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).
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
Ostatní jména:
|
|
Experimentální: 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.
Ostatní jména:
|
|
Jiný: 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.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Incidence of postoperative complications
Časové okno: 1 month
|
1 month
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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- 2026-0280
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