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Starting soon Observational

Early Kidney Injury Biomarkers in Gynecologic Laparoscopic Surgery

NCT07704242 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2026-08-01
Last updated
2026-07-15

Condition(s) studied

Acute Kidney InjurySubclinical Acute Kidney Injury

Investigational drug(s) / intervention(s)

Pneumoperitoneum and Trendelenburg Positioning

Pneumoperitoneum and Trendelenburg Positioning: Standard intraoperative carbon dioxide pneumoperitoneum combined with either 30° or 45° Trendelenburg positioning during laparoscopic surgery

Study summary

This prospective observational study aims to evaluate early subclinical acute kidney injury associated with pneumoperitoneum and Trendelenburg positioning during gynecological laparoscopic surgery. Urinary neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1) levels will be measured and normalized to urinary creatinine. Biomarker changes will be compared between patients undergoing surgery in 30° and 45° Trendelenburg positions. The study seeks to determine whether these biomarkers can detect early renal injury before clinically significant changes in serum creatinine occur.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Female participants aged 18 years or older. Scheduled for elective gynecological laparoscopic surgery. Expected duration of pneumoperitoneum of at least 90 minutes. Planned intraoperative Trendelenburg position of approximately 30° or 45°. Ability to provide written informed consent. - Exclusion Criteria: Age younger than 18 years. Pre-existing chronic kidney disease (estimated glomerular filtration rate \<60 mL/min/1.73 m² or serum creatinine above the institutional upper limit of normal). Acute kidney injury before surgery. History of kidney transplantation or renal replacement therapy. Active urinary tract infection. Pregnancy. Conversion from laparoscopic to open surgery. Intraoperative conditions requiring major deviation from the standardized anesthetic or surgical protocol. Inability to provide written informed consent. \-

Primary outcome measure(s)

  • Perioperative Changes in Urinary Renal Tubular Injury Biomarkers — Baseline (after induction of anesthesia and urinary catheterization) and postoperative 6 hours.
    Perioperative changes in urinary neutrophil gelatinase-associated lipocalin (NGAL)/creatinine and kidney injury molecule-1 (KIM-1)/creatinine ratios from baseline (after induction of anesthesia and urinary catheterization) to the sixth postoperative hour. Biomarker changes will be compared between participants undergoing surgery in approximately 30° and 45° Trendelenburg positions

Trial sites (1)

FacilityCityRegionStatus
Medipol Mega University Hospital Istanbul Istanbul
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07704242 on ClinicalTrials.gov ↗ ← All trials in Turkey