Using Retrograde Intrarenal Surgery for Managing Staghorn Renal Stones.
ConditionRenal Calculi
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHelwan University
About this trial
This prospective, randomized study is comparing the safety and efficacy of using two types of ureteral access sheaths in managing staghorn renal stones by retrograde intrarenal surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients of both sexes.
Patient has a staghorn renal stone (complete or partial staghorn).
Normal renal function tests.
Congenital renal anomalies as horseshoe, pelvic or mal-rotated kidneys.
Disqualifiers
Abnormal coagulation profile.
Active or untreated urinary tract infection.
Age under 18 years or above 70 years.
Patient has a staghorn stone associated with other pathology which requires additional intervention, as ureteral stricture or ureteropelvic junction obstruction (UPJO).
Trial design
Design model
Parallel
Treatments tested in this trial
Retrograde intrarenal surgery
Procedure/SurgeryRetrograde intrarenal surgery with using laser for management of renal staghorn stones
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Group (1): Retrograde intrarenal surgery using a bendable tip-suction ureteral access sheathActive comparator 1 intervention
Group B: Group (2): Retrograde intrarenal surgery using a conventional ureteral access sheathPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Safety of the surgical technique
Evaluating and comparing the incidence of operative and postoperative complications
Time frame
During surgery to one month after surgerySecondary outcomes
1
The efficacy of the surgery
Stone-free rates of the patients will be evaluated by computed tomography after surgery.
Time frame
One month after surgerySponsors and contacts
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Source ClinicalTrials.gov