- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07360795
Do We Really Bleed in Percutaneous Nephrolithotomy? A Single-Surgeon, Single-Center Experience
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
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Elâzığ
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Elâzığ, Elâzığ, Turkey (Türkiye), 23100
- Elazığ Fethi Sekin City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
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.
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The difference between preoperative and postoperative hemoglobin levels (g/dL) will be evaluated in patients undergoing percutaneous nephrolithotomy
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From the preoperative baseline to postoperative day 1 and throughout the length of hospital stay.
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Secondary Outcome Measures
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.
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The change in hematocrit (%) values between the preoperative and postoperative periods will be assessed
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From the preoperative baseline to postoperative day 1 and throughout the length of hospital stay.
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Estimated Intraoperative Blood Loss
Time Frame: During the surgical procedure.
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Estimated blood loss (mL) during percutaneous nephrolithotomy will be assessed based on intraoperative surgical records.
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During the surgical procedure.
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Postoperative Blood Transfusion Requirement
Time Frame: From postoperative day 1 until hospital discharge.
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The need for postoperative blood transfusion (yes/no) and the number of transfused packed red blood cell units will be recorded.
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From postoperative day 1 until hospital discharge.
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urolithiasis
- Surgical Procedures, Operative
- Minimally Invasive Surgical Procedures
- Endoscopy
- Urologic Surgical Procedures
- Urogenital Surgical Procedures
- Laparoscopy
- Nephrolithotomy, Percutaneous
Other Study ID Numbers
- FSCH-SB-2025-PCNL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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