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

NCT ID: NCT05648877

Last Updated: 2023-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2023-04-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Retrograde Intrarenal Surgery In Management Of Renal Stones

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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43 semirigid ureteropyeloscopy

43 Patients underwent semirigid ureteropyeloscopy

Group Type EXPERIMENTAL

Ureteroscope

Intervention Type DEVICE

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

34 flexible ureteropyeloscopy

34 patients with flexible ureteropyeloscopy

Group Type ACTIVE_COMPARATOR

Ureteroscope

Intervention Type DEVICE

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

Interventions

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Ureteroscope

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Uncorrected coagulopathy Distal obstruction Active urinary tract infection Ureteropelvic junction obstruction Congenital renal anomalies Staghorn stones
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Menoufia University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Ali abdelghaffar

Menoufia gevernorate

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Menoufia faculty of medicine

Shibīn al Kawm, Monufia Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohammed A Abdelghaffar, Bachelor

Role: CONTACT

01555950089 ext. Menoufia

Facility Contacts

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Mohammed A Abdelghaffar, Bachelor

Role: primary

01555950089

Other Identifiers

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11/2020 urol

Identifier Type: -

Identifier Source: org_study_id

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