Bilateral Synchronous Simultaneous Stone Surgery

Sponsor

Marmara University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03599297

Collaborator

(none)

100

Enrollment

Location

Arm

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Kidney Calculi Nephrolithotomy, Percutaneous Ureteroscopy	Procedure: Bilateral synchronous simultaneous stone surgery	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2018

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Stone free rate [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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marmara University Hospital	Istanbul		Turkey	34890

Sponsors and Collaborators

Marmara University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marmara University

ClinicalTrials.gov Identifier:

NCT03599297

Other Study ID Numbers:

MAR.UAD.003

First Posted:

Jul 26, 2018

Last Update Posted:

Apr 1, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Kidney Calculi

Nephrolithiasis

Calculi

Study Results

No Results Posted as of Apr 1, 2022