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A Comparative Study of Three Ureteral Stenting Strategies After Ureteroscopic Lithotripsy for Upper Urinary Tract Calculi

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Zhejiang University

Status

Not yet enrolling

Conditions

Upper Urinary Tract Calculi

Treatments

Procedure: Upper urinary tract calculi

Study type

Interventional

Funder types

Other

Identifiers

NCT07616505
2026-0280

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 3 patient groups

Intervention group1
Experimental group
Description:
Double-J stent indwelling for 1 week postoperatively
Treatment:
Procedure: Upper urinary tract calculi
Intervention group2
Experimental group
Description:
no Double-J stent insertion
Treatment:
Procedure: Upper urinary tract calculi
Control group
Other group
Description:
Double-J stent indwelling for 2 weeks postoperatively
Treatment:
Procedure: Upper urinary tract calculi

Trial contacts and locations

0

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Central trial contact

Hong He

Data sourced from clinicaltrials.gov

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