Early Kidney Injury Biomarkers in Gynecologic Laparoscopic Surgery (NCT07704242) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Early Kidney Injury Biomarkers in Gynecologic Laparoscopic Surgery
Turkey (Türkiye)50 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
\-
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is measuring urinary biomarkers for early kidney injury during laparoscopic gynecologic surgery — does my planned surgery carry a meaningful risk of acute kidney injury that would make it worth monitoring this closely?
2Since this trial isn't recruiting yet, how long might it be before I could even consider participating, and does that timeline affect my treatment or surgery schedule?
3The study focuses on 'subclinical' acute kidney injury, meaning kidney stress that might not show up on standard tests — is that something my care team already monitors routinely, or is this trial offering something I wouldn't otherwise get?
4Because this trial is listed as Phase NA, it sounds more like an observational study than a treatment trial — can you help me understand what, if anything, would be different about my care or surgery if I were to participate?
5Are there standard post-surgical kidney monitoring protocols already in place for my procedure, and how would joining this study compare to what I'd receive through normal care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Perioperative Changes in Urinary Renal Tubular Injury Biomarkers
Timeframe: Baseline (after induction of anesthesia and urinary catheterization) and postoperative 6 hours.