to Study the Role of Retrograde Intrarenal Surgery in Management of Renal Stones
Primary Purpose
Retrograde Intrarenal Surgery In Management Of Renal Stones
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ureteroscope
Sponsored by
About this trial
This is an interventional treatment trial for Retrograde Intrarenal Surgery In Management Of Renal Stones focused on measuring Renal pelvic stone, Semi-rigid URS, Flexible URS, Treatment
Eligibility Criteria
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
Sites / Locations
- Menoufia faculty of medicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
43 semirigid ureteropyeloscopy
34 flexible ureteropyeloscopy
Arm Description
43 Patients underwent semirigid ureteropyeloscopy
34 patients with flexible ureteropyeloscopy
Outcomes
Primary Outcome Measures
stone free rates and complications
Stone free rates of both semirigid and flexible URS
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05648877
Brief Title
to Study the Role of Retrograde Intrarenal Surgery in Management of Renal Stones
Official Title
Role Of Retrograde Intrarenal Surgery In Management Of Renal Stones: Single Center Experience
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
February 25, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Role Of Retrograde Intrarenal Surgery In Management Of Renal Stones: Single Center Experience
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retrograde Intrarenal Surgery In Management Of Renal Stones
Keywords
Renal pelvic stone, Semi-rigid URS, Flexible URS, Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
77 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
43 semirigid ureteropyeloscopy
Arm Type
Experimental
Arm Description
43 Patients underwent semirigid ureteropyeloscopy
Arm Title
34 flexible ureteropyeloscopy
Arm Type
Active Comparator
Arm Description
34 patients with flexible ureteropyeloscopy
Intervention Type
Device
Intervention Name(s)
Ureteroscope
Intervention Description
Role Of Retrograde Intrarenal Surgery In Management Of Renal Stones: Single Center Experience
Primary Outcome Measure Information:
Title
stone free rates and complications
Description
Stone free rates of both semirigid and flexible URS
Time Frame
Up to 6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed A Abdelghaffar, Bachelor
Phone
01555950089
Ext
Menoufia
Email
mohammed20207501@gmail.com
Facility Information:
Facility Name
Menoufia faculty of medicine
City
Shibin-al-Kawm
State/Province
Al-Minufiyah
ZIP/Postal Code
32616
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed A Abdelghaffar, Bachelor
Phone
01555950089
Email
mohammed20207501@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
After completing the thesis, I'll share IPD to other researchers
IPD Sharing Time Frame
October 2022
IPD Sharing Access Criteria
Clinical trial.gov
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