Acute Kidney InjuryNCT07704242
Early Kidney Injury Biomarkers in Gynecologic Laparoscopic Surgery
An observational study of Acute Kidney Injury and Subclinical Acute Kidney Injury, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate early subclinical acute kidney injury associated with pneumoperitoneum and Trendelenburg positioning during gynecological laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Acute Kidney Injury, Subclinical Acute Kidney Injury
- What is being tested?
- Pneumoperitoneum and Trendelenburg Positioning
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2026to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
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.
-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Medipol Mega University Hospital
Istanbul, Istanbul, 34214
Isilay Ayar Gecginer, MD, +902124607000 ext. 10233, iayar@medipol.edu.tr
Isilay Ayar Gecginer, MD
About this study
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
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.
Read the 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.
- Being tested
- Pneumoperitoneum and Trendelenburg Positioning
- Keywords
- NGAL, KIM-1, Gynecologic Laparoscopy, Pneumoperitoneum, Trandelenburg Position, Acute Kidney Injury, Biomarker, Renal Injury
- Medical subject headings
- Acute Kidney Injury, Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumoperitoneum and Trendelenburg PositioningProcedure or surgery
Standard intraoperative carbon dioxide pneumoperitoneum combined with either 30° or 45° Trendelenburg positioning during laparoscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Pneumoperitoneum and Trendelenburg Positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (after induction of anesthesia and urinary catheterization) and postoperative 6 hours.
Secondary outcomes (2)
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
Measured: 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
Comparison of perioperative changes in urinary NGAL/creatinine and KIM-1/creatinine ratios between the 30° and 45° Trendelenburg cohorts
Measured: Baseline (after induction of anesthesia and urinary catheterization) and postoperative 6 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isilay Ayar Gecginer, Istanbul Medipol University Hospital
- Investigators
- Isilay Ayar Gecginer, MD, Principal investigator, Istanbul Medipol University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704242
- Sponsor's protocol ID
- E-10840098-202.3.02-990
- Other IDs
- 2026/19
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 30348111Villa 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.
PubMed 38664893Kiseli 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.
PubMed 28144124
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07704242
- Acronym / sponsor ID
- E-10840098-202.3.02-990
- Keywords
- NGAL, KIM-1, Gynecologic Laparoscopy, Pneumoperitoneum, Trandelenburg Position, Acute Kidney Injury, Biomarker, Renal Injury
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30° Trendelenburg Group | – | Procedure: Pneumoperitoneum and Trendelenburg PositioningParticipants 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. |
| 45° Trendelenburg Group | – | Procedure: Pneumoperitoneum and Trendelenburg PositioningParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pneumoperitoneum and Trendelenburg PositioningStandard intraoperative carbon dioxide pneumoperitoneum combined with either 30° or 45° Trendelenburg positioning during laparoscopic surgery | Procedure or surgery | 30° Trendelenburg Group, 45° Trendelenburg Group |
Primary outcome
Perioperative Changes in Urinary Renal Tubular Injury Biomarkers
Time frame: Baseline (after induction of anesthesia and urinary catheterization) and postoperative 6 hours.
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
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Background: PubMed 30348111Srisawat 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.
- Background: PubMed 38664893Villa 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.
- Background: PubMed 28144124Kiseli 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Isilay Ayar Gecginer, MD principal investigator
Istanbul Medipol University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Subclinical Acute Kidney Injury, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isilay Ayar Gecginer, MD (+902124607000 ext. 10233, iayar@medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative Changes in Urinary Renal Tubular Injury Biomarkers (time frame: Baseline (after induction of anesthesia and urinary catheterization) and postoperative 6 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07704242, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.