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Efficacy And Safety Of Antegrade Uretroscopic Lithotripsy Versus Retrograde Ureteroscopic Lithotripsy In The Treatment Of Upper Ureteric Stones Measuring > 10 mm In Maximum Dimension. A Randomized Comparative Study

Efficacy And Safety Of Antegrade Uretroscopic Lithotripsy Versus Retrograde Ureteroscopic Lithotripsy In The Treatment Of Upper Ureteric Stones Measuring > 10 mm In Maximum Dimension. A Randomized Comparative Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07362784
Acronym
mm millimeter
Enrollment
100
Registered
2026-01-23
Start date
2022-03-15
Completion date
2025-09-14
Last updated
2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper Ureteric Stones

Keywords

flexible ureteroscopy, proximal ureteric stones, laser

Brief summary

This study aims to assess the efficacy and safety of antegrade flexible ureteroscopic lithotripsy in treating upper ureteric stones \>10 mm in maximum dimension and impacted upper ureteric stones irrespective of size in comparison to retrograde ureteroscopic lithotripsy and evaluate feasibility, adverse events, hospital stay and cost benefit of both techniques

Detailed description

Study included 100 patients meeting the inclusion criteria for having an upper urteric stone larger than 10 mm in maximum diameter from the level of pelviureteric junction to upper border of sacroiliac junction and aged ≥18 years. Stones were deemed impacted in case of lack of movement for 1 month on 2 computed tomography scans of urinary tract (CTUT) or non passage of guide wire and / or dye intraoperatively. Exclusion criteria were unresolved urinary tract infection, uncorrected coagulopathy, pregnancy, anatomical abnormalities of the urinary system as horse shoe kidney, pelvic ectopic kidney and ureteric strictures, severe orthopedic malformation hindering prone position or antegrade ureteric access as kyphosis and scoliosis, Pediatric age groups \< 18 years, ureteric Stent in place, concurrent renal stones, bladder cancer, upper urothelial tumors or renal tumors. All patients signed an informed consent and were randomized by closed envelop method into 2 groups: group A included 50 patients treated by antegrade flexible URSL and group B included 50 patients treated by retrograde flexible URSL. Preoperatively, all patients underwent evaluation by medical history, physical examination, laboratory work up including complete blood count (CBC), kidney functions test, liver functions test, hepatitis markers, coagulation profile, completer urine analysis and urine culture with sensitivity. All patients were subjected to imaging studies including pelvi-abdominal ultrasound, plain X-ray of urinary tract and CTUT. Postoperatively, all patient had CBC done a few hours after the procedure, monitored for vital signs and urine color. All patients were assessed for residual stone presence 3 weeks after procedure by CTUT. Stone free status was defined by absence of stone fragment of 4 mm or more in maximum diameter. The primary endpoint was stone free rate. Secondary endpoints were complications, operative time, fluoroscopy time, mean hemoglobin drop, hospital stay and need for auxiliary procedures.

Interventions

PROCEDUREantegrade flexible ureteroscopy for group A

The antegrade approach with this stone size will further prove the superior stone free rate compared with the retrograde approach, widen the indication for the antegrade approach and prove the more favorable perioperative safety profile

PROCEDUREretrograde flexible ureteroscopy For group B

he antegrade approach with this stone size will further prove the superior stone free rate compared with the retrograde approach, widen the indication for the antegrade approach and prove the more favorable perioperative safety profile

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients with upper urteric stone larger than 10 mm in maximum diameter from the level of pelviureteric junction to upper border of sacroiliac junction and aged ≥18 years

Exclusion criteria

* unresolved urinary tract infection, uncorrected coagulopathy, pregnancy, anatomical abnormalities of the urinary system as horse shoe kidney, pelvic ectopic kidney and ureteric strictures, severe orthopedic malformation hindering prone position or antegrade ureteric access as kyphosis and scoliosis, Pediatric age groups \< 18 years, ureteric Stent in place, concurrent renal stones, bladder cancer, upper urothelial tumors or renal tumors

Design outcomes

Primary

MeasureTime frameDescription
stone free rate3 weeks after the interventionstone free rate was compared between the 2 arms

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026