NCT05340075

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

March 30, 2022

Last Update Submit

April 20, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • BMI in kg/m^2

    BMI in kg/m\^2

    3 Months

  • rates of intraoperative blood transfusion, operation time(minute)

    rates of intraoperative blood transfusion, operation time(minute)

    3 Months

Secondary Outcomes (1)

  • mm size of the stone,

    3 Months

Study Arms (2)

Staged percutaneous nephrolithotomy group 1

Those who underwent percutaneous nephrolithotomy 2-4 weeks after percutaneous nephrolithotomy for stones in the other kidney

Procedure: Patients who underwent percutaneous nephrolithotomy

Staged percutaneous nephrolithotomy group 2

Those who underwent percutaneous nephrolithotomy 4-6 weeks after percutaneous nephrolithotomy for stones in the other kidney

Procedure: Patients who underwent percutaneous nephrolithotomy

Interventions

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

Staged percutaneous nephrolithotomy group 1Staged percutaneous nephrolithotomy group 2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with stones of 2 cm or more in each kidney

You may qualify if:

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

You may not qualify if:

  • Renal Failure
  • Coagulopathy
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Training and Research Hospital

Ankara, Altindag, 06230, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 29149365BACKGROUND
  • 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.

    PMID: 30031834BACKGROUND
  • 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.

    PMID: 33331579BACKGROUND

MeSH Terms

Conditions

Kidney CalculiUrolithiasis

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 30, 2022

First Posted

April 21, 2022

Study Start

September 15, 2021

Primary Completion

December 15, 2021

Study Completion

January 20, 2022

Last Updated

April 21, 2022

Record last verified: 2022-04

Locations