CClinicalTrials.gg
Status unknownNCT05648877Updated Jan 18, 2023

to Study the Role of Retrograde Intrarenal Surgery in Management of Renal Stones

An interventional study of Ureteroscope in Retrograde Intrarenal Surgery In Management Of Renal Stones, sponsored by Menoufia University. Status unknown at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2023-01-18.

Sponsored by Menoufia University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
77
Allocation
Non-randomized
Sex
All
01

Study summary

Role Of Retrograde Intrarenal Surgery In Management Of Renal Stones: Single Center Experience

Read the detailed description

With the advancements in endourologic technology, in the last 30 years, renal stone treatment has dramatically changed, and minimally invasive treatments options, such as extracorporeal shock wave lithotripsy (SWL), percutaneous nephrolithotomy (PCNL), mini-PCNL, retrograde intrarenal surgery (RIRS) or laparoscopy, have replaced open surgery.

Although, minimally invasive treatment modalities have an excellent stone fragmentation rate, the clearance of stone fragments may not be immediate and can occur for any time after the intervention.

The European Association of Urology (EAU) guidelines, recommends PCNL for renal stones greater than 2 cm, and SWL is suggested primarily for stones less than 1 cm in size. Although SWL, RIRS and PCNL are all presented as treatment options for renal stones between, which application is a matter of preference.

The treatment modality selection of renal stones usually depends on stone-related factors (location, size, and composition), clinical factors (patient's comorbidities, patient's compliance, solitary kidney, and abnormal anatomy), and technical factors (equipment available for treatment, success rates, possible complications, invasiveness, the need for anesthetics, hospitalization times, and costs).

PCNL can achieve better results but is more invasive, is associated with greater morbidity and complications, and may be reserved for selected circumstances.

Stone clearance following kidney stone treatment is not well defined. For lower pole stones, Sener and colleagues compared RIRS with SWL and reported a stone-free rate of 52.3% with patients treated using RIRS one week after treatment. However after three months, the stone-free rate improved to 100%.

Ureteroscopic lithotripsy has been the most widely applied treatment for urinary tract stones, with high success and low complication rates. The holmium laser has facilitated the disintegration of stones and increased the effectiveness of ureteroscopic lithotripsy.

Improvements in the new generation of flexible ureteroscopes have made retrograde endoscopic ureteroscopy and laser lithotripsy for renal calculi more popular. The overall success rates of retrograde intrarenal surgery have been reported as 75% to 95% for intrarenal stones > 2 cm after the first or second treatment, whereas the major and minor complication rates vary from 1.5% to 12%, which are less frequent than rates in PCNL procedures.

02

Conditions studied

  • Retrograde Intrarenal Surgery In Management Of Renal Stones

Keywords

  • Renal pelvic stone
  • Semi-rigid URS
  • Flexible URS
  • Treatment
03

In context

Kidney Calculi

598 studies on the registry are indexed under Kidney Calculi; 163 are open to participants now.

This study's planned enrollment of 77 is below the median of 90 across 461 interventional studies indexed under Kidney Calculi.

Browse Kidney Calculi studies →

Lead sponsor

Menoufia University is the lead sponsor of 192 studies on the registry; 53 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All patients with renal stones were eligible for the procedure. Patients with difficult PCNL

Exclusion criteria

Exclusion Criteria:

  • Uncorrected coagulopathy Distal obstruction Active urinary tract infection Ureteropelvic junction obstruction Congenital renal anomalies Staghorn stones
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
77 participants (estimated)

Study arms

  • Experimental
    43 semirigid ureteropyeloscopy

    43 Patients underwent semirigid ureteropyeloscopy

    Device: Ureteroscope

  • Active comparator
    34 flexible ureteropyeloscopy

    34 patients with flexible ureteropyeloscopy

    Device: Ureteroscope

Interventions

  • DeviceUreteroscope

    Role Of Retrograde Intrarenal Surgery In Management Of Renal Stones: Single Center Experience

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What researchers measure

Primary outcomes

  1. stone free rates and complications

    Stone free rates of both semirigid and flexible URS

    Time frame: Up to 6 months

07

Study locations

1 of 1 sites recruiting
  • Menoufia faculty of medicine
    Shibin-al-Kawm, Al-Minufiyah 32616, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — After completing the thesis, I'll share IPD to other researchers

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05648877
Lead sponsor
Menoufia University
Responsible party
Mohammed Ali abdelghaffar (Menoufia gevernorate, Menoufia University) — Principal investigator
First posted
Dec 13, 2022
Start date
Oct 1, 2020
Primary completion
Feb 25, 2023 (estimated)
Completion
Apr 1, 2023 (estimated)
Last update
Jan 18, 2023

Study contacts

Mohammed A Abdelghaffar, Bachelor
Contact
mohammed20207501@gmail.com
01555950089 ext. Menoufia

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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