Health TrialsbyHealthPanel

Early Kidney Injury Biomarkers in Gynecologic Laparoscopic Surgery

ConditionsAcute Kidney InjurySubclinical Acute Kidney Injury
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMedipol University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

The study population will consist of adult women undergoing elective gynecological laparoscopic surgery at a single tertiary care center. Eligible participants are those with an anticipated pneumoperitoneum duration of at least 90 minutes and a planned intraoperative Trendelenburg position of approximately 30° or 45°, according to routine surgical practice. Participants will be enrolled prospectively after providing written informed consent.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Pneumoperitoneum and Trendelenburg Positioning

    Procedure/Surgery

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: 30° Trendelenburg Group1 intervention
Group B: 45° Trendelenburg Group1 intervention

Trial outcomes

Primary outcomes

1

Perioperative Changes in Urinary Renal Tubular Injury Biomarkers

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

Time frame
Baseline (after induction of anesthesia and urinary catheterization) and postoperative 6 hours.

Secondary outcomes

1

Association Between Urinary Biomarker Changes and Duration of Pneumoperitoneum

Association between perioperative changes in urinary NGAL/creatinine and KIM-1/creatinine ratios and the total duration of pneumoperitoneum

Time frame
From induction of anesthesia until completion of surgery, with biomarker assessment at baseline and postoperative 6 hours
2

Comparison of Urinary Biomarker Changes According to Trendelenburg Position

Comparison of perioperative changes in urinary NGAL/creatinine and KIM-1/creatinine ratios between the 30° and 45° Trendelenburg cohorts

Time frame
Baseline (after induction of anesthesia and urinary catheterization) and postoperative 6 hours.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medipol University

Lead sponsor

Istanbul Medipol University Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: