Retrograde Intrarenal Surgery Versus Extracorporeal Shockwave Lithotripsy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorSindh Institute of Urology and Transplantation
About this trial
The study's aim is to determine which treatment modality, either ESWL or RIRS, is more effective in achieving stone clearance for lower calyceal calculi.
Investigators hypothesize that retrograde intrarenal surgery is better as compared to extracorporeal shockwave lithotripsy. It will target those patients suffering from kidney stones in lower calyces with sizes up to 1.5 cm in an open-label, randomized controlled trial.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Those patients will be included with lower calyceal renal stones and size up to 1.5 cm.
Patients' ages will be between 18 and 60 years.
Both genders will be included.
Disqualifiers
Untreated Urine culture positive will be excluded
Patients using anticoagulants and females with pregnancies and those lactating will be excluded.
Anatomical abnormalities like horseshoe kidney, duplex system, pelvic kidney, malrotated kidney, calyceal diverticulum, steep infundibulopelvic angle, infundibular stenosis, long infundibular length/narrow infundibular width, pelvic ureteric junction obstruction, ureterocele, and ureteral stricture will be excluded.
Trial design
Design model
Parallel
Treatments tested in this trial
Retrograde intrarenal surgery
Procedure/SurgeryRetrograde intrarenal surgery (RIRS) is a minimally invasive procedure in which a flexible ureteroscope is passed through the urethra, then the ureter, and then into the kidney, and then with the help of the laser, stones are broken down into small fragments, which can be retrieved either at the same time or flushed later in urine. Stone clearance will assessed with an X-ray of the abdomen (radiopaque) and ultrasound or CT scan of the kidneys (residual radiolucent stones) on follow-up.
Extracorporeal shock wave lithotripsy
Procedure/SurgeryExtracorporeal shock wave lithotripsy (ESWL) is a noninvasive procedure in which highly focused shock waves are delivered at the renal calculi, which then break down into small pieces and later pass in urine. An X-ray abdomen (radiopaque) and ultrasound or CT scan of the kidneys (residual radiolucent stone) will be used on follow-up to assess stone clearance. Up to 3 sessions of ESWL will given to the selected candidate
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Group AActive comparator 1 intervention
Group B: Group BExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Stone clearance
Stone clearance (based on follow-up with X-Ray for radio-opaque stones and ultrasound or CT Scan for radio-lucent stones)
Time frame
four weeks after the interventionSecondary outcomes
1
Urinary tract infection
It is diagnosed if the patient starts complaining of burning micturition along with a running temperature. It will be confirmed by a urine D/R with a culture \& sensitivity report.
Time frame
within 4 weeks after the intervention2
Hematuria
It will be diagnosed if the patient starts complaining of burning micturition along with red discoloration of urine. It will be confirmed by the presence of numerous RBCs in a urine D/R
Time frame
within 4 weeks after the interventionSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: