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

NCT07360795 | Completed

• 1 other identifier: FSCH-SB-2025-PCNL
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urolithiasis

Keywords

Perkütan Nefrolitotomi; Clavien-Dindo Sınıflandırması; Kan Transfüzyonu

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin Level

  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 Outcomes (3)

• Change in Hematocrit Level

  From the preoperative baseline to postoperative day 1 and throughout the length of hospital stay.

• Estimated Intraoperative Blood Loss

  During the surgical procedure.

• Postoperative Blood Transfusion Requirement

  From postoperative day 1 until hospital discharge.

Study Arms (1)

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

Interventions

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.

Percutaneous Nephrolithotomy (PCNL) Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elazıg Fethi Sekin Sehir Hastanesi: lead

Study Sites (1)

Elazığ Fethi Sekin City Hospital

Elâzığ, Elâzığ, 23100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urolithiasis

Interventions

Nephrolithotomy, Percutaneous

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 22, 2026
• Study Start: August 1, 2022
• Primary Completion: December 20, 2025
• Study Completion: December 20, 2025
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)