NCT07854743

Brief Summary

This prospective, single-center observational study evaluated patients undergoing staged bilateral standard percutaneous nephrolithotomy (PCNL) for bilateral renal stones. Each participant underwent PCNL on one kidney followed by contralateral PCNL in a separate session, allowing a paired within-patient comparison in which each patient served as their own control. The study aimed to compare operative, hematologic, renal, inflammatory, stone-free, and complication outcomes between the first and second PCNL procedures. In addition, the association between the inter-stage interval and second-side outcomes was explored, with particular emphasis on systemic inflammatory response assessed using neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammation index (SII).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2026

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2026

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 2, 2026

Completed
Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

4.6 years

First QC Date

September 27, 2026

Last Update Submit

September 27, 2026

Conditions

Keywords

Systemic Inflammatory Response SyndromeAcute Kidney InjuryInflammationNephrolithotomy, Percutaneous

Outcome Measures

Primary Outcomes (1)

  • Change in Neutrophil-to-Lymphocyte Ratio (ΔNLR) After PCNL

    The neutrophil-to-lymphocyte ratio (NLR) was calculated from absolute neutrophil and lymphocyte counts obtained preoperatively and on postoperative day 1 (POD1) for each PCNL session. ΔNLR was defined as POD1 NLR minus preoperative NLR. ΔNLR was compared between the first- and second-side PCNL procedures using a paired within-patient design.

    From preoperative assessment to postoperative day 1 after each PCNL procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with bilateral renal stones who underwent staged bilateral standard PCNL at Ankara Training and Research Hospital. Each participant underwent PCNL on one kidney followed by contralateral PCNL in a separate session, allowing paired within-patient assessment of the two procedures.

You may qualify if:

  • Age ≥18 years.
  • Bilateral renal stones requiring staged bilateral standard percutaneous nephrolithotomy (PCNL).
  • Undergoing PCNL of one kidney followed by contralateral PCNL in a separate session.

You may not qualify if:

  • Age \<18 years.
  • Positive preoperative urine culture.
  • Use of preoperative antibiotics.
  • Presence of an indwelling urinary drainage catheter before PCNL, including a urethral catheter, ureteral stent, or percutaneous nephrostomy.
  • Previous renal surgery on the same kidney.
  • Renal tumor.
  • Chronic renal failure.
  • Congenital renal malformation.
  • Chronic use of oral immunosuppressive agents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arif Bedirhan Bayraktar

Ankara, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

NephrolithiasisSystemic Inflammatory Response SyndromeAcute Kidney InjuryInflammation

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsShockRenal Insufficiency

Study Officials

  • Arif Bedirhan Bayraktar

    Ankara Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 27, 2026

First Posted

October 2, 2026

Study Start

February 1, 2022

Primary Completion

August 21, 2026

Study Completion

September 15, 2026

Last Updated

October 2, 2026

Record last verified: 2026-09

Locations