Staged Bilateral Percutaneous Nephrolithotomy

Urolithiasis Clinical Trial

Official title:

Staged Bilateral Percutaneous Nephrolithotomy: When to Operate for a Contralateral Kidney?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05340075
• Other study ID #: PCNL2022
• Status: Completed
• Start date: September 15, 2021
• Est. completion date: January 20, 2022

Study information

• Verified date: April 2022
• Source: Ankara Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To determine the optimal time between the first and second operations in patients with bilateral kidney stones and scheduled percutaneous nephrolithotomy for the contralateral kidney. Patients who underwent percutaneous nephrolithotomy to the contralateral kidney 2-4 weeks and 4-6 weeks after the first operation will be compared.

Description:

The aim of the study is to determine the optimal time between the first and second operations in patients with bilateral kidney stones and scheduled percutaneous nephrolithotomy for the contralateral kidney. In our study, patients who underwent percutaneous nephrolithotomy to the contralateral kidney 2-4 weeks and 4-6 weeks after the first operation will be compared. With the guidance of preoperative and postoperative data, it is aimed to determine the optimal time with the lowest complication and highest operational success.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 20, 2022
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with stones of 2 cm or more in each kidney

Exclusion Criteria:

• Renal Failure

• Coagulopathy

• Pregnancy

Related Conditions & MeSH terms

• Kidney Calculi
• Nephrolithiasis
• Stone, Kidney
• Urolithiasis

Intervention

Procedure:
• Patients who underwent percutaneous nephrolithotomy
Patients who underwent percutaneous nephrolithotomy to the contralateral kidney 2-4 weeks and 4-6 weeks after the percutaneous nephrolithotomy operation

Locations

Country	Name	City	State
Turkey	Ankara Training and Research Hospital	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

ElSheemy MS, Ghoneima W, Elmarakbi AA, Al-Kandari AM, Ibrahim H, Shrestha S, Khadgi S. Bilateral Single-session vs Staged Mini-percutaneous Nephrolithotomy for Renal Stones: A Comparative Study. Urology. 2018 Oct;120:62-67. doi: 10.1016/j.urology.2018.07.015. Epub 2018 Jul 20. — View Citation

Torricelli FCM, Carvalho RS, Marchini GS, Danilovic A, Vicentini FC, Batagello CA, Srougi M, Nahas WC, Mazzucchi E. Bilateral simultaneous percutaneous nephrolithotomy versus staged approach: a critical analysis of complications and renal function. Rev Assoc Med Bras (1992). 2020 Dec;66(12):1696-1701. doi: 10.1590/1806-9282.66.12.1696. — View Citation

Wollin DA, Preminger GM. Percutaneous nephrolithotomy: complications and how to deal with them. Urolithiasis. 2018 Feb;46(1):87-97. doi: 10.1007/s00240-017-1022-x. Epub 2017 Nov 17. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI in kg/m^2	BMI in kg/m^2	3 Months
Primary	rates of intraoperative blood transfusion, operation time(minute)	rates of intraoperative blood transfusion, operation time(minute)	3 Months
Secondary	mm size of the stone,	mm size of the stone,	3 Months