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Completed

NCT Number: 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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Elazığ Fethi Sekin City Hospital

Elâzığ, 23100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

percutaneous nephrolithotomy

Procedure

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Elazıg Fethi Sekin Sehir Hastanesi

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 22, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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