NCT07635160

Brief Summary

This prospective observational study aims to evaluate renal perfusion in adult patients undergoing elective minimally invasive abdominal surgery. Renal perfusion will be assessed using two non-invasive monitoring techniques: Doppler ultrasonography-derived Renal Resistive Index (RRI) and Near-Infrared Spectroscopy (NIRS)-derived renal regional oxygen saturation (rSO₂). Measurements will be obtained at predefined perioperative time points, including after induction of anesthesia, during pneumoperitoneum, before extubation, and during the early postoperative period. Perioperative changes in renal perfusion parameters will be analyzed and correlated with clinical variables such as intra-abdominal pressure, pneumoperitoneum duration, hemodynamic parameters, fluid administration, urine output, and postoperative renal function. The study also aims to investigate the relationship between intraoperative renal perfusion changes and the development of postoperative acute kidney injury. The findings may contribute to improved perioperative monitoring and optimization of renal perfusion during minimally invasive abdominal surgery.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress44%
Jan 2026Jan 2027

Study Start

First participant enrolled

January 7, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2027

Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 3, 2026

Last Update Submit

June 3, 2026

Conditions

Keywords

Kidney Perfusion,Renal Resistive Index,Near-Infrared Spectroscopy,Acute Kidney Injury,Laparoscopic Surgery

Outcome Measures

Primary Outcomes (2)

  • Change in Renal Regional Oxygen Saturation Measured by NIRS

    Renal regional oxygen saturation (rSO₂) will be measured bilaterally using Near-Infrared Spectroscopy (NIRS). NIRS values will be recorded at predefined perioperative time points.

    after endotracheal intubation, immediately before extubation, and 1 hour after extubation

  • Change in Renal Resistive Index

    Renal Resistive Index (RRI) measured by Doppler ultrasonography at predefined perioperative time points. RRI will be calculated from peak systolic velocity and end-diastolic velocity obtained from renal interlobar or arcuate arteries.

    after endotracheal intubation, immediately before extubation, and 1 hour after extubation

Secondary Outcomes (1)

  • Relationship Between Renal Resistive Index and Renal Regional Oxygen Saturation

    after endotracheal intubation, immediately before extubation, and 1 hour after extubation

Study Arms (1)

Elective Minimally Invasive Abdominal Surgery Patients

Adult patients aged 18 to 80 years undergoing elective minimally invasive abdominal surgery under general anesthesia. Renal perfusion will be assessed perioperatively and postoperatively(postoperative 1. hour) using Doppler ultrasonography-derived Renal Resistive Index (RRI) and Near-Infrared Spectroscopy (NIRS)-derived regional renal oxygen saturation (rSO₂). Measurements will be performed at predefined perioperative time points and correlated with intraoperative variables, postoperative renal function, and the occurrence of acute kidney injury.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients aged 18-80 years with ASA physical status I-III undergoing elective minimally invasive abdominal surgery at Istanbul University-Cerrahpaşa Faculty of Medicine. Patients will be prospectively evaluated for perioperative renal perfusion using Doppler ultrasonography and Near-Infrared Spectroscopy (NIRS).

You may qualify if:

  • Patients aged 18 to 80 years
  • Patients with ASA physical status I, II, or III
  • Patients undergoing elective minimally invasive abdominal surgery for any reason
  • Patients whose expected surgical duration is longer than 1 hour

You may not qualify if:

  • Body mass index greater than 35 kg/m²
  • Severe respiratory system disease
  • Severe heart failure, NYHA class III-IV
  • Presence of a cardiac pacemaker or cardiac defibrillator implant
  • Progressive neuromuscular disease
  • High intra-abdominal pressure
  • Sudden deterioration of general condition
  • Incomplete clinical or laboratory data
  • Refusal to participate in the study
  • Conversion to open surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Cerrahpaşa Faculty of Medicine

Istanbul, 34320, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Lyudmila MARTYNENKO AYDOGDU, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

June 3, 2026

First Posted

June 9, 2026

Study Start

January 7, 2026

Primary Completion (Estimated)

January 7, 2027

Study Completion (Estimated)

January 7, 2027

Last Updated

June 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared because the study was not designed with a data-sharing plan and participant confidentiality will be protected in accordance with institutional and ethical requirements.

Locations