Vacuum-Assisted Mini-Percutaneous Versus Transurethral Cystolithotripsy in Pediatric Bladder Stones
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-14
SponsorBeni-Suef University
About this trial
This prospective randomized pilot study will compare vacuum-assisted mini-percutaneous cystolithotripsy with standard transurethral cystolithotripsy for the treatment of bladder stones in children. Forty children aged 2 to 14 years with bladder stone(s) measuring 10 -30 mm will be randomly assigned to one of two surgical approaches. The vacuum-assisted mini-percutaneous group will undergo suprapubic percutaneous access using a mini sheath with suction-assisted fragment evacuation, while the transurethral group will undergo standard transurethral cystolithotripsy. The primary outcome will be total operative time. Secondary outcomes will include stone-free rate ,lithotripsy time and fragment clearance time, urethral mucosal injury, postoperative hematuria, fever, urinary tract infection, sepsis, urinary retention, urinary leakage from the suprapubic tract, catheterization time, hospital stay, postoperative pain, analgesic requirement, need for auxiliary procedures or conversion, and recurrence or urethral stricture-related symptoms during follow-up.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged 2 to 14 years.
Diagnosis of bladder stone or stones measuring 10-30 mm in maximum cumulative diameter, confirmed by ultrasound.
Normal upper urinary tract.
Fit for general anesthesia.
Disqualifiers
Known urethral stricture or posterior urethral valves.
Active urinary tract infection at the time of surgery.
Coagulopathy or uncorrected bleeding disorder.
Previous open bladder surgery.
Trial design
Design model
Parallel
Treatments tested in this trial
Vacuum-Assisted Mini-Percutaneous Cystolithotripsy
Procedure/SurgerySurgical treatment of pediatric bladder stones using suprapubic mini-percutaneous bladder access, a suction-assisted mini sheath, and Ho:YAG laser lithotripsy for stone fragmentation and evacuation
Transurethral Cystolithotripsy
Procedure/SurgeryStandard transurethral endoscopic treatment of pediatric bladder stones using an appropriate pediatric semi-rigid ureteroscope with Ho:YAG laser lithotripsy and transurethral fragment evacuation
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Vacuum-Assisted Mini-Percutaneous CystolithotripsyExperimental treatment 1 intervention
Group B: Transurethral CystolithotripsyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Total Operative Time
Total operative time will be defined as the time from insertion of the first endoscopic instrument to completion of stone clearance and urethral catheter placement, measured in minutes.
Time frame
IntraoperativeSecondary outcomes
1
Stone-Free Rate
Stone-free rate will be defined as the proportion of patients with no residual bladder stone fragments on postoperative pelvi abdominl ultrasound. Low-dose non-contrast CT urinary tract will be reserved for equivocal ultrasound findings. Time Frame: 4 weeks postoperatively
Time frame
4 weeks postoperatively2
Urethral Mucosal Injury
Occurrence of visible urethral mucosal injury detected intraoperatively.
Time frame
Intraoperatively3
Lithotripsy and Fragment Clearance Time
Time from initiation of laser lithotripsy to endoscopic confirmation of complete stone clearance, measured in minutes.
Time frame
Intraoperative4
Recurrence or Urethral Stricture-Related Symptoms
Occurrence of recurrent bladder stone symptoms, abnormal urinary stream, suspected urethral stricture symptoms, or need for further diagnostic evaluation
Time frame
6 months postoperativelySponsors and contacts
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Source ClinicalTrials.gov