Early Kidney Injury Biomarkers in Gynecologic Laparoscopic Surgery

NCT07704242 | Not Yet Recruiting DMC

• 2 other identifiers: E-10840098-202.3.02-9902026/19
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Kidney Injury; Subclinical Acute Kidney Injury

Keywords

NGAL; KIM-1; Gynecologic Laparoscopy; Pneumoperitoneum; Trandelenburg Position; Acute Kidney Injury; Biomarker; Renal Injury

Outcome Measures

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

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

Secondary Outcomes (2)

• Association Between Urinary Biomarker Changes and Duration of Pneumoperitoneum

  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

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

Study Arms (2)

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.

Procedure: Pneumoperitoneum and Trendelenburg Positioning

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.

Procedure: Pneumoperitoneum and Trendelenburg Positioning

Interventions

Pneumoperitoneum and Trendelenburg Positioning PROCEDURE

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

30° Trendelenburg Group; 45° Trendelenburg Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Medipol Mega University Hospital

Istanbul, Istanbul, 34214, Turkey (Türkiye)

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Perioperative urine samples will be collected for the measurement of urinary neutrophil gelatinase-associated lipocalin (NGAL), kidney injury molecule-1 (KIM-1), and urinary creatinine. Urinary creatinine will be used to normalize NGAL and KIM-1 concentrations, and biomarker results will be expressed as NGAL/creatinine and KIM-1/creatinine ratios for analysis.

MeSH Terms

Conditions

Acute Kidney Injury; Pneumoperitoneum

Interventions

Head-Down Tilt

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Peritoneal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Isilay Ayar Gecginer, MD

  Istanbul Medipol University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isilay Ayar Gecginer, MD

CONTACT

+902124607000; iayar@medipol.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 15, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)