Bilateral Synchronous Simultaneous Stone Surgery
Evaluation of Efficacy and Safety Profile of Bilateral Synchronous Simultaneous Stone Surgery for Kidney Stones
1 other identifier
interventional
100
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2018
CompletedFirst Posted
Study publicly available on registry
July 26, 2018
CompletedStudy Start
First participant enrolled
September 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedAugust 7, 2023
August 1, 2023
5.3 years
June 4, 2018
August 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Complications
at the 1st week of surgery
Post operative urinary diversion
at the 24th hour of surgery
Radiation exposure
At 1st hour of surgery
Hemoglobin level change
from baseline to 24th hour of surgery
Hospital stay
will be assessed through completion of study, an average of 1 year.
- +1 more secondary outcomes
Study Arms (1)
Bilateral synchronous simultaneous stone surgery
EXPERIMENTALPatients who will be operated for kidney stones at both their kidneys in a single surgery session will be included in the study. Patients will undergo percutaneous nephrolithotomy for one side and flexible ureteroscopy for the other side.
Interventions
Patients undergoing Bilateral synchronous simultaneous stone surgery (one kidney undergoing percutaneous nephrolithotomy, other kidney undergoing ureteroscopy at the same time in a single patient)
Eligibility Criteria
You may qualify if:
- patients scheduled for kidney stone surgery according to European Association Urology, Urolithiasis guidelines
- patients with bilateral kidney stones
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Marmara University Hospital
Istanbul, 34890, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yiloren Tanidir, Ass. Prof.
Marmara University, School of Medicine, Department of Urology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2018
First Posted
July 26, 2018
Study Start
September 1, 2018
Primary Completion
December 31, 2023
Study Completion
February 1, 2024
Last Updated
August 7, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share
The data will not be shared.