UrolithiasisNCT07360795
Do We Really Bleed in Percutaneous Nephrolithotomy? A Single-Surgeon, Single-Center Experience
An observational study of Urolithiasis, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urolithiasis
- What is being tested?
- Percutaneous Nephrolithotomy
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 20 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Elazığ Fethi Sekin City Hospital
Elâzığ, Elâzığ, 23100
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.
Read the 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.
- Conditions
- Urolithiasis
- Being tested
- Percutaneous Nephrolithotomy
- Keywords
- Perkütan Nefrolitotomi, Clavien-Dindo Sınıflandırması, Kan Transfüzyonu
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous NephrolithotomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Percutaneous Nephrolithotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin Level
The difference between preoperative and postoperative hemoglobin levels (g/dL) will be evaluated in patients undergoing percutaneous nephrolithotomy
Measured: From the preoperative baseline to postoperative day 1 and throughout the length of hospital stay.
Secondary outcomes (3)
Change in Hematocrit Level
The change in hematocrit (%) values between the preoperative and postoperative periods will be assessed
Measured: From the preoperative baseline to postoperative day 1 and throughout the length of hospital stay.
Estimated Intraoperative Blood Loss
Estimated blood loss (mL) during percutaneous nephrolithotomy will be assessed based on intraoperative surgical records.
Measured: During the surgical procedure.
Postoperative Blood Transfusion Requirement
The need for postoperative blood transfusion (yes/no) and the number of transfused packed red blood cell units will be recorded.
Measured: From postoperative day 1 until hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Aug 2022
- Primary completion20 Dec 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elazıg Fethi Sekin Sehir Hastanesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360795
- Sponsor's protocol ID
- FSCH-SB-2025-PCNL
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do We Really Bleed in Percutaneous Nephrolithotomy? A Single-Surgeon, Single-Center Experience
- ClinicalTrials.gov ID
- NCT07360795
- Acronym / sponsor ID
- FSCH-SB-2025-PCNL
- Conditions
- Urolithiasis
- Keywords
- Perkütan Nefrolitotomi, Clavien-Dindo Sınıflandırması, Kan Transfüzyonu
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Elazıg Fethi Sekin Sehir HastanesiUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Nephrolithotomy (PCNL) Cohort | – | Procedure: Percutaneous NephrolithotomyPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous NephrolithotomyPercutaneous 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. | Procedure or surgery | Percutaneous Nephrolithotomy (PCNL) Cohort |
Primary outcome
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
3 secondary outcomes
Change in Hematocrit Level
Time frame: 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.
Postoperative Blood Transfusion Requirement
Time frame: From postoperative day 1 until hospital discharge.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urolithiasis, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin Level (time frame: From the preoperative baseline to postoperative day 1 and throughout the length of hospital stay.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026; AzTrials last refreshed its copy on 27 Oct 2026.