Bilateral Synchronous Simultaneous Stone Surgery

Not Applicable

Recruiting

• Conditions: Ureteroscopy; Kidney Calculi; Nephrolithotomy, Percutaneous
• Interventions: Procedure: Bilateral synchronous simultaneous stone surgery

• Registration Number: NCT03599297
• Lead Sponsor: Marmara University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-04
• Study First Submitted QC: 2018-07-23
• Study First Posted: 2018-07-26
• Study Start: 2018-09-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-07
• Primary Completion: 2023-12-31
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bilateral synchronous simultaneous stone surgery	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Complications	at the 1st week of surgery	Complications are assessed according to Clavien Dindo classification
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
Hemoglobin level change	from baseline to 24th hour of surgery	The amount of hemoglobin drop during and after surgery
Residual stone	at the 24th hour of surgery	The diameter of the stones that couldn't be retracted

Trial Locations

Locations (1)

Marmara University Hospital; 🇹🇷 Istanbul, Turkey