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Role of Pre-stenting Before Retrograde Intrarenal Surgery With Miniaturized Flexible Ureteroscopes

ConditionRenal Calculi
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAl-Azhar University

About this trial

This prospective randomized controlled trial will compare retrograde intrarenal surgery performed after routine preoperative ureteral stenting with direct retrograde intrarenal surgery without planned preoperative stenting in adults with unilateral renal calculi measuring 10-20 mm. The study will evaluate stone-free rate, ureteral access, need for rescue stenting, operative outcomes, complications, staged procedures, postoperative recovery, and auxiliary treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18-70 years.

Unilateral renal calculi.

Maximum total renal stone burden of 10-20 mm.

Planned treatment with RIRS.

Disqualifiers

Bilateral renal calculi requiring simultaneous surgical treatment.

Active urinary tract infection, sepsis, or infected obstruction requiring urgent drainage.

Solitary kidney when randomization is considered clinically unsafe.

Known ureteral stricture or congenital ureteral abnormality likely to interfere with ureteroscopic access.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Preoperative double-J ureteral stenting followed by retrograde intrarenal surgery

    Procedure/Surgery

    Participants randomized to this group will undergo insertion of a 4.8-6 French double-J ureteral stent approximately 7-14 days before definitive RIRS. The stent will be used to provide passive ureteral dilation. Definitive RIRS will then be performed using a miniaturized digital flexible ureteroscope and holmium:YAG laser lithotripsy. The stent size, length, date of insertion, dwell time, technical success, complications, urinary tract infection, and stent-related symptoms will be recorded.

  • Direct retrograde intrarenal surgery without planned preoperative ureteral stenting

    Procedure/Surgery

    Participants randomized to this group will undergo direct RIRS without planned preoperative ureteral stenting. No routine active ureteral dilation will be performed before initial access. Gentle dilation may be performed when clinically necessary and will be documented. If safe access cannot be achieved, the procedure will be discontinued and a double-J ureteral stent will be inserted for passive dilation. Repeat RIRS will be scheduled approximately 7-14 days later.

Treatment groups

270 Participants
are divided into 2 treatment groups
Group A: Pre-stenting groupExperimental treatment 1 intervention
Group B: No-pre-stenting groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Stone-free rate

Stone-free status will be assessed using postoperative non-contrast computed tomography. The primary analysis will define stone-free status as absence of any residual renal stone fragment greater than 2 mm.

Time frame
Four weeks after the final RIRS procedure

Secondary outcomes

1

Successful renal access

Successful access is defined as passage of the flexible ureteroscope into the renal collecting system without unsafe resistance, significant ureteral injury, or procedure abandonment.

Time frame
During the initial RIRS procedure
2

Need for active ureteral dilation

Proportion of participants requiring active ureteral dilation to facilitate safe ureteroscope or access-sheath passage.

Time frame
During the initial RIRS procedure
3

Intraoperative ureteral injury

Ureteral injury, including mucosal abrasion, submucosal injury, perforation, false passage, significant edema, or ureteral avulsion, documented according to a predefined injury classification.

Time frame
During each RIRS procedure
4

Postoperative complications

Postoperative complications will include fever, urinary tract infection, sepsis, hematuria, renal colic, urinary retention, ureteral obstruction, stent migration, stent encrustation, ureteral stricture, emergency-department visits, readmission, and the need for emergency or auxiliary treatment. Complications will be graded using the Clavien-Dindo classification.

Time frame
From the initial RIRS procedure through 30 days after the final RIRS procedure

Other outcomes

Sponsors and contacts

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Al-Azhar University

Lead sponsor

Source ClinicalTrials.gov
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