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Not yet recruiting NCT07704242

Early Kidney Injury Biomarkers in Gynecologic Laparoscopic Surgery

Observational Acute Kidney Injury Subclinical Acute Kidney Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pneumoperitoneum and Trendelenburg Positioning.
Who it may be relevant to
Registry conditions: Acute Kidney Injury, Subclinical Acute Kidney Injury. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparative Analysis of Urinary NGAL and KIM-1 Levels in Predicting Subclinical Acute Kidney Injury Secondary to Pneumoperitoneum and Deep Trendelenburg Position in Gynecological Laparoscopic Surgery

Overview

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.

Detailed description

This single-center, prospective observational study aims to evaluate the effects of pneumoperitoneum and Trendelenburg positioning on early renal tubular injury during elective gynecological laparoscopic surgery. Although laparoscopic surgery provides well-established surgical benefits, carbon dioxide pneumoperitoneum combined with prolonged Trendelenburg positioning may reduce renal perfusion through alterations in intra-abdominal pressure and systemic hemodynamics. Conventional assessment of renal function relies primarily on serum creatinine, which may not increase until substantial nephron injury has occurred, limiting the early detection of subclinical acute kidney injury (AKI).

Adult patients scheduled for elective gynecological laparoscopic procedures with an anticipated operative duration of at least 90 minutes will be screened for eligibility. To minimize perioperative variability, anesthetic management, intraoperative fluid therapy, and perioperative care will be standardized for all participants according to the Enhanced Recovery After Surgery (ERAS) recommendations. Intra-abdominal pressure will be maintained within the routine clinical range of 12-14 mmHg throughout the procedure.

Participants will be allocated into two cohorts according to the Trendelenburg angle required for the planned surgical procedure: a 30° Trendelenburg group and a 45° Trendelenburg group. No intervention regarding patient positioning will be performed for study purposes, and group allocation will be based solely on routine surgical practice.

Urine samples will be collected at predefined time points: after induction of anesthesia and urinary catheterization (baseline) and at the sixth postoperative hour. Urinary neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1) concentrations will be measured using enzyme-linked immunosorbent assay (ELISA). To reduce the influence of urine dilution and hydration status, biomarker concentrations will be normalized to urinary creatinine and expressed as NGAL/creatinine and KIM-1/creatinine ratios.

The study sample size was determined by power analysis, with a target enrollment of 50 participants. Statistical analyses will evaluate perioperative changes in urinary NGAL/creatinine and KIM-1/creatinine ratios between baseline and the postoperative period. Biomarker changes will be compared between the 30° and 45° Trendelenburg groups and analyzed in relation to the duration of pneumoperitoneum.

This study aims to determine whether perioperative changes in urinary NGAL and KIM-1 are associated with the degree of Trendelenburg positioning and the duration of pneumoperitoneum during gynecological laparoscopic surgery. The findings are expected to improve the understanding of early renal tubular stress associated with laparoscopic surgery and provide preliminary evidence for future studies investigating strategies to preserve renal function during minimally invasive surgical procedures.

Interventions

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

Primary outcome measures

  • Perioperative Changes in Urinary Renal Tubular Injury Biomarkers [Time frame: Baseline (after induction of anesthesia and urinary catheterization) and postoperative 6 hours.]
Secondary outcome measures (2)
  • Association Between Urinary Biomarker Changes and Duration of Pneumoperitoneum [Time frame: From induction of anesthesia until completion of surgery, with biomarker assessment at baseline and postoperative 6 hours]
  • Comparison of Urinary Biomarker Changes According to Trendelenburg Position [Time frame: Baseline (after induction of anesthesia and urinary catheterization) and postoperative 6 hours.]

Eligibility criteria

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.

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Medipol Mega University Hospital — Istanbul

Publications

  • Srisawat N, Kongwibulwut M, Laoveeravat P, Lumplertgul N, Chatkaew P, Saeyub P, Latthaprecha K, Peerapornratana S, Tiranathanagul K, Eiam-Ong S, Tungsanga K. The role of intraoperative parameters on predicting laparoscopic abdominal surgery associated acute kidney injury. BMC Nephrol. 2018 Oct 22;19(1):289. doi: 10.1186/s12882-018-1081-4. PMID 30348111
  • Villa G, Fiorentino M, Cappellini E, Lassola S, De Rosa S. Renal implications of pneumoperitoneum in laparoscopic surgery: mechanisms, risk factors, and preventive strategies. Korean J Anesthesiol. 2024 Dec;77(6):575-586. doi: 10.4097/kja.24011. Epub 2024 Apr 26. PMID 38664893
  • Kiseli M, Caglar GS, Yilmaz H, Gursoy AY, Candar T, Pabuccu EG, Bengisun ZK, Tuzuner F. Neutrophil Gelatinase-Associated Lipocalin Levels During Pneumoperitoneum. JSLS. 2017 Jan-Mar;21(1):e2016.00091. doi: 10.4293/JSLS.2016.00091. PMID 28144124

Identifiers

NCT: NCT07704242 · E-10840098-202.3.02-990 · 2026/19

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗