Bilateral Synchronous Simultaneous Stone Surgery
Primary Purpose
Kidney Calculi, Nephrolithotomy, Percutaneous, Ureteroscopy
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bilateral synchronous simultaneous stone surgery
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Calculi
Eligibility Criteria
Inclusion Criteria:
- patients scheduled for kidney stone surgery according to European Association Urology, Urolithiasis guidelines
- patients with bilateral kidney stones
Exclusion Criteria:
- none
Sites / Locations
- Marmara University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bilateral synchronous simultaneous stone surgery
Arm Description
Patients 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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Complications
Complications are assessed according to Clavien Dindo classification
Post operative urinary diversion
evaluation of patients whether they have a nephrostomy or a ureteral stent at the end of the operation
Radiation exposure
The cumulative fluoroscopy dose that was emitted during surgery
Hemoglobin level change
The amount of hemoglobin drop during and after surgery
Hospital stay
The amount of days that the patient stayed at the hospital
Residual stone
The diameter of the stones that couldn't be retracted
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03599297
Brief Title
Bilateral Synchronous Simultaneous Stone Surgery
Official Title
Evaluation of Efficacy and Safety Profile of Bilateral Synchronous Simultaneous Stone Surgery for Kidney Stones
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Calculi, Nephrolithotomy, Percutaneous, Ureteroscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bilateral synchronous simultaneous stone surgery
Arm Type
Experimental
Arm Description
Patients 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.
Intervention Type
Procedure
Intervention Name(s)
Bilateral synchronous simultaneous stone surgery
Intervention Description
Patients undergoing Bilateral synchronous simultaneous stone surgery (one kidney undergoing percutaneous nephrolithotomy, other kidney undergoing ureteroscopy at the same time in a single patient)
Primary Outcome Measure Information:
Title
Stone free rate
Description
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
Time Frame
at the 24th hour of the surgery
Secondary Outcome Measure Information:
Title
Complications
Description
Complications are assessed according to Clavien Dindo classification
Time Frame
at the 1st week of surgery
Title
Post operative urinary diversion
Description
evaluation of patients whether they have a nephrostomy or a ureteral stent at the end of the operation
Time Frame
at the 24th hour of surgery
Title
Radiation exposure
Description
The cumulative fluoroscopy dose that was emitted during surgery
Time Frame
At 1st hour of surgery
Title
Hemoglobin level change
Description
The amount of hemoglobin drop during and after surgery
Time Frame
from baseline to 24th hour of surgery
Title
Hospital stay
Description
The amount of days that the patient stayed at the hospital
Time Frame
will be assessed through completion of study, an average of 1 year.
Title
Residual stone
Description
The diameter of the stones that couldn't be retracted
Time Frame
at the 24th hour of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients scheduled for kidney stone surgery according to European Association Urology, Urolithiasis guidelines
patients with bilateral kidney stones
Exclusion Criteria:
none
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yiloren Tanidir, Ass. Prof.
Phone
00905325694275
Email
yiloren@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tarik Emre Sener, Urologist
Phone
00905337620712
Email
dr.emresener@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yiloren Tanidir, Ass. Prof.
Organizational Affiliation
Marmara University, School of Medicine, Department of Urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marmara University Hospital
City
Istanbul
ZIP/Postal Code
34890
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiloren Tanidir, Ass.Prof.
Phone
00905325694275
Email
yiloren@yahoo.com
First Name & Middle Initial & Last Name & Degree
Tarik Emre Sener, M.D.
Phone
00905337620712
Email
dr.emresener@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data will not be shared.
Learn more about this trial
Bilateral Synchronous Simultaneous Stone Surgery
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