Bilateral Synchronous Simultaneous Stone Surgery

August 3, 2023 updated by: Marmara University

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yiloren Tanidir, Ass. Prof.
  • Phone Number: 00905325694275
  • Email: yiloren@yahoo.com

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey, 34890
        • Recruiting
        • Marmara University Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients scheduled for kidney stone surgery according to European Association Urology, Urolithiasis guidelines
  • patients with bilateral kidney stones

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bilateral synchronous simultaneous stone surgery
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.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone free rate
Time Frame: at the 24th hour of the surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: at the 1st week of surgery
Complications are assessed according to Clavien Dindo classification
at the 1st week of surgery
Post operative urinary diversion
Time Frame: at the 24th hour of surgery
evaluation of patients whether they have a nephrostomy or a ureteral stent at the end of the operation
at the 24th hour of surgery
Radiation exposure
Time Frame: At 1st hour of surgery
The cumulative fluoroscopy dose that was emitted during surgery
At 1st hour of surgery
Hemoglobin level change
Time Frame: from baseline to 24th hour of surgery
The amount of hemoglobin drop during and after surgery
from baseline to 24th hour of surgery
Hospital stay
Time Frame: will be assessed through completion of study, an average of 1 year.
The amount of days that the patient stayed at the hospital
will be assessed through completion of study, an average of 1 year.
Residual stone
Time Frame: at the 24th hour of surgery
The diameter of the stones that couldn't be retracted
at the 24th hour of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Investigators

  • Principal Investigator: Yiloren Tanidir, Ass. Prof., Marmara University, School of Medicine, Department of Urology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

June 4, 2018

First Submitted That Met QC Criteria

July 23, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAR.UAD.003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data will not be shared.

IPD Sharing Time Frame

The data will be available at the end of the study (which is planned to be at the end of 2019)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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