Early Kidney Injury Biomarkers in Gynecologic Laparoscopic Surgery

Sponsor
Medipol University
Study ID
NCT07704242
Status
Not Yet Recruiting

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Conditions

  • Acute Kidney Injury
  • Subclinical Acute Kidney Injury

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jul 15, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Feb 1, 2027
Completion
Mar 1, 2027

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: 30° Trendelenburg Group
    Participants undergoing elective gynecological laparoscopic surgery requiring approximately 30° Trendelenburg positioning as part of routine surgical practice. Perioperative urinary NGAL, KIM-1, and urinary creatinine will be measured to evaluate changes in renal tubular injury biomarkers. Group allocation is based solely on the surgical positioning required for the planned procedure, with no study-related intervention.
  • Arm: 45° Trendelenburg Group
    Participants undergoing elective gynecological laparoscopic surgery requiring approximately 45° Trendelenburg positioning as part of routine surgical practice. Perioperative urinary NGAL, KIM-1, and urinary creatinine will be measured to evaluate changes in renal tubular injury biomarkers. Group allocation is based solely on the surgical positioning required for the planned procedure, with no study-related intervention.

Primary Outcome Measure

Perioperative Changes in Urinary Renal Tubular Injury Biomarkers [ Time Frame: Baseline (after induction of anesthesia and urinary catheterization) and postoperative 6 hours. ]

Central Contacts

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