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NCT03599297 Clinical Trial

Bilateral Synchronous Simultaneous Stone Surgery

Kidney Calculi Clinical Trial

Official title:
Evaluation of Efficacy and Safety Profile of Bilateral Synchronous Simultaneous Stone Surgery for Kidney Stones

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03599297
Other study ID # MAR.UAD.003
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date February 1, 2024

Study information
Verified date August 2023
Source Marmara University
Contact Yiloren Tanidir, Ass. Prof.
Phone 00905325694275
Email yiloren@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Advancements in technology and endourological armamentarium provides multiple surgical options for complicated stone patients. To avoid multiple operations and shorten the total operation durations, bilateral synchronous simultaneous stone surgery (BSSSS) has been popularized in recent years. Our aim is to evaluate the preliminary outcomes of BSSSS in patients undergoing supine percutaneous nephrolithotomy (PCNL) and retrograde intrarenal surgery (RIRS).

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date February 1, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - patients scheduled for kidney stone surgery according to European Association Urology, Urolithiasis guidelines - patients with bilateral kidney stones Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Bilateral synchronous simultaneous stone surgery
Patients undergoing Bilateral synchronous simultaneous stone surgery (one kidney undergoing percutaneous nephrolithotomy, other kidney undergoing ureteroscopy at the same time in a single patient)

Locations
Country Name City State
Turkey Marmara University Hospital Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Stone free rate stone free status is decided according to both the immediate evaluation of the endoscopic view at the end of the operation and the post operative imaging with kidney, ureter, bladder X-ray at the 24th hour of the surgery at the 24th hour of the surgery
Secondary Complications Complications are assessed according to Clavien Dindo classification at the 1st week of surgery
Secondary Post operative urinary diversion evaluation of patients whether they have a nephrostomy or a ureteral stent at the end of the operation at the 24th hour of surgery
Secondary Radiation exposure The cumulative fluoroscopy dose that was emitted during surgery At 1st hour of surgery
Secondary Hemoglobin level change The amount of hemoglobin drop during and after surgery from baseline to 24th hour of surgery
Secondary Hospital stay The amount of days that the patient stayed at the hospital will be assessed through completion of study, an average of 1 year.
Secondary Residual stone The diameter of the stones that couldn't be retracted at the 24th hour of surgery
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