Staged Bilateral Percutaneous Nephrolithotomy

April 20, 2022 updated by: Ali Kaan Yildiz, Ankara Training and Research Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

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

Study Locations

  • Turkey
    • Altindag
      • Ankara, Altindag, Turkey, 06230
        • Ankara Training and Research Hospital

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with stones of 2 cm or more in each kidney

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Renal Failure
  • Coagulopathy
  • Pregnancy

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

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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 2
Those who underwent percutaneous nephrolithotomy 4-6 weeks after percutaneous nephrolithotomy for stones in the other kidney
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI in kg/m^2
Time Frame: 3 Months
BMI in kg/m^2
3 Months
rates of intraoperative blood transfusion, operation time(minute)
Time Frame: 3 Months
rates of intraoperative blood transfusion, operation time(minute)
3 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mm size of the stone,
Time Frame: 3 Months
mm size of the stone,
3 Months

Collaborators and Investigators

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

Sponsor

Ankara Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 15, 2021

Primary Completion (Actual)

December 15, 2021

Study Completion (Actual)

January 20, 2022

Study Registration Dates

First Submitted

March 30, 2022

First Submitted That Met QC Criteria

April 20, 2022

First Posted (Actual)

April 21, 2022

Study Record Updates

Last Update Posted (Actual)

April 21, 2022

Last Update Submitted That Met QC Criteria

April 20, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCNL2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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