Do We Really Bleed in Percutaneous Nephrolithotomy? A Single-Surgeon, Single-Center Experience

January 17, 2026 updated by: Elazıg Fethi Sekin Sehir Hastanesi

Percutaneous nephrolithotomy (PCNL) is an effective and guideline-recommended surgical technique for the treatment of large and complex renal stones; however, perioperative bleeding remains one of its most significant complications. Reported bleeding and transfusion rates vary widely in the literature, potentially due to differences in surgical technique, surgeon experience, and institutional practices.

This retrospective, single-center study aims to evaluate perioperative and postoperative bleeding outcomes, transfusion requirements, and bleeding-related complications in patients who underwent PCNL performed by a single surgeon. The findings are intended to clarify whether the real-world bleeding risk associated with PCNL is lower than commonly reported.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Percutaneous nephrolithotomy (PCNL) is an effective and guideline-recommended surgical technique for the treatment of large and complex renal stones; however, perioperative bleeding remains one of its most significant complications. Reported bleeding and transfusion rates vary widely in the literature, potentially due to differences in surgical technique, surgeon experience, and institutional practices.

This retrospective, single-center study aims to evaluate perioperative and postoperative bleeding outcomes, transfusion requirements, and bleeding-related complications in patients who underwent PCNL performed by a single surgeon. The findings are intended to clarify whether the real-world bleeding risk associated with PCNL is lower than commonly reported. This is a retrospective, single-center observational study conducted at Elazığ Fethi Sekin City Hospital, Türkiye. Medical records of patients who underwent percutaneous nephrolithotomy between August 1, 2022, and December 20, 2025, will be reviewed retrospectively using the hospital information management system and anesthesia records.

All PCNL procedures were performed by a single experienced urologist using standardized surgical techniques. Demographic characteristics, perioperative variables, laboratory values, bleeding parameters, transfusion requirements, postoperative outcomes, and complications will be analyzed. Surgical complications will be classified according to the Clavien-Dindo classification system.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

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 (Türkiye)
    • Elâzığ
      • Elâzığ, Elâzığ, Turkey (Türkiye), 23100
        • Elazığ Fethi Sekin City 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with nephrolithiasis who underwent percutaneous nephrolithotomy at a single tertiary care center. The study population consists of adult patients treated by a single surgeon, with perioperative and postoperative outcomes evaluated retrospectively.

Description

Inclusion Criteria:

  • Patients who underwent percutaneous nephrolithotomy (PCNL)
  • Availability of complete intraoperative and postoperative follow-up data
  • Availability of preoperative and postoperative complete blood count and biochemical laboratory results

Exclusion Criteria:

  • Pregnancy
  • Conversion to open or laparoscopic surgery during PCNL
  • Simultaneous additional surgical procedures, bilateral or synchronous bilateral PCNL
  • Known coagulation disorders, hematological diseases, or active bleeding in the preoperative period
  • Use of anticoagulant or antiplatelet therapy without appropriate perioperative management
  • Preoperative blood transfusion requirement
  • Severe intraoperative hemodynamic instability affecting the surgical course
  • Missing hemoglobin or hematocrit data, insufficient transfusion or complication records
  • Inadequate postoperative follow-up or transfer to another institutionConversion to open or laparoscopic surgery during PCNL
  • Simultaneous additional surgical procedures, bilateral or synchronous bilateral PCNL
  • Known coagulation disorders, hematological diseases, or active bleeding in the preoperative period
  • Use of anticoagulant or antiplatelet therapy without appropriate perioperative management
  • Preoperative blood transfusion requirement
  • Severe intraoperative hemodynamic instability affecting the surgical course
  • Missing hemoglobin or hematocrit data, insufficient transfusion or complication records
  • Inadequate postoperative follow-up or transfer to another institution

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Percutaneous Nephrolithotomy (PCNL) Cohort
Patients who underwent percutaneous nephrolithotomy performed by a single surgeon at a single tertiary care center. This retrospective cohort includes patients whose perioperative and postoperative bleeding outcomes, transfusion requirements, and surgical complications were evaluated using existing medical records.
Procedure: Percutaneous Nephrolithotomy
Percutaneous nephrolithotomy performed according to standard clinical practice for the treatment of renal calculi. All procedures were completed by a single experienced surgeon. No additional intervention, modification, or experimental procedure was applied as part of the study. Data related to perioperative and postoperative bleeding outcomes were collected retrospectively from existing medical records.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Hemoglobin Level
Time Frame: From the preoperative baseline to postoperative day 1 and throughout the length of hospital stay.
The difference between preoperative and postoperative hemoglobin levels (g/dL) will be evaluated in patients undergoing percutaneous nephrolithotomy
From the preoperative baseline to postoperative day 1 and throughout the length of hospital stay.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Hematocrit Level
Time Frame: From the preoperative baseline to postoperative day 1 and throughout the length of hospital stay.
The change in hematocrit (%) values between the preoperative and postoperative periods will be assessed
From the preoperative baseline to postoperative day 1 and throughout the length of hospital stay.
Estimated Intraoperative Blood Loss
Time Frame: During the surgical procedure.
Estimated blood loss (mL) during percutaneous nephrolithotomy will be assessed based on intraoperative surgical records.
During the surgical procedure.
Postoperative Blood Transfusion Requirement
Time Frame: From postoperative day 1 until hospital discharge.
The need for postoperative blood transfusion (yes/no) and the number of transfused packed red blood cell units will be recorded.
From postoperative day 1 until hospital discharge.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Elazıg Fethi Sekin Sehir Hastanesi

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FSCH-SB-2025-PCNL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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