Flexible Ureteroscopy Versus Percutaneous Nephrolithotomy As Primary Treatment in Renal Stones 2-3 Cm
1 other identifier
interventional
122
1 country
1
Brief Summary
Flexible Ureteroscopy versus Percutaneous Nephrolithotomy as Primary Treatment in Renal Stones 2-3 Cm
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedFirst Submitted
Initial submission to the registry
March 10, 2025
CompletedFirst Posted
Study publicly available on registry
March 25, 2025
CompletedMarch 25, 2025
March 1, 2025
1.6 years
March 10, 2025
March 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
stone free rate percentage defined as number of patients who have no stone residual
assessed by Plain urinary tract and ultrasound for confirmation of the presence of residual stone fragments.
18 months
Study Arms (2)
RIRS
EXPERIMENTALRIRS performed in lithotomy position for which guide wire pass to the kidney, then passing ureteral dilators up to 14F and ureteral access sheath. Dusting stones by RIRS and holmium laser Fiber 200 mm, at the end of operation DJ was fixed.
PNL
EXPERIMENTALPNL performed in prone position, after passing guide wire and ureteric catheter in lithotomy position. Puncture to the kidney, passing 2 wires, then using renal dilators and access sheath to enter kidney by nephroscopy, fragment stones by pneumatic and remove stones, then place nelaton 28F at end of operation.
Interventions
RIRS performed in lithotomy position for which guide wire pass to the kidney, then passing ureteral dilators up to 14F and ureteral access sheath. Dusting stones by RIRS and holmium laser Fiber 200 mm, at the end of operation DJ was fixed.
PNL performed in prone position, after passing guide wire and ureteric catheter in lithotomy position. Puncture to the kidney, passing 2 wires, then using renal dilators and access sheath to enter kidney by nephroscopy, fragment stones by pneumatic and remove stones, then place nelaton 28F at end of operation
Eligibility Criteria
You may qualify if:
- stone burden from 2- 3 cm, single or multiple stones and radio-opaque or radio-lucent stones.
You may not qualify if:
- stone burden from 2- 3 cm, single or multiple stones and radio-opaque or radio-lucent stones.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Hesham Torad
Cairo, Cairo Governorate, 38516, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
March 10, 2025
First Posted
March 25, 2025
Study Start
January 1, 2022
Primary Completion
August 1, 2023
Study Completion
August 1, 2023
Last Updated
March 25, 2025
Record last verified: 2025-03