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| ID | Type | Description | Link |
|---|---|---|---|
| 2026/19 | Other Grant/Funding Number | Istanbul Medipol University Scientific Research Projects Coordination Unit |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumoperitoneum and Trendelenburg Positioning | Procedure | Standard intraoperative carbon dioxide pneumoperitoneum combined with either 30° or 45° Trendelenburg positioning during laparoscopic surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From induction of anesthesia until completion of surgery, with biomarker assessment at baseline and postoperative 6 hours |
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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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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isilay Ayar Gecginer, MD | Contact | +902124607000 | 10233 | iayar@medipol.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Isilay Ayar Gecginer, MD | Istanbul Medipol University Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medipol Mega University Hospital | Istanbul | Istanbul | 34214 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30348111 | Background | 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. | |
| 38664893 |
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Individual participant data will not be made publicly available. Data were collected for the purposes of this investigator-initiated academic study and may contain information that could compromise participant confidentiality. Only aggregated study results will be reported in publications and presentations.
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D011027 | Pneumoperitoneum |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D018475 | Head-Down Tilt |
| ID | Term |
|---|---|
| D011187 | Posture |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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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.
| 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 |
| Baseline (after induction of anesthesia and urinary catheterization) and postoperative 6 hours. |
| 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. |
| 28144124 | 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. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |